latis Over-the-Wire Graft Cleaning Catheter A4GW6Recalls & reported problems

Summary

The FDA's MAUDE database contains 12 adverse event reports that list this exact device (DI 00607915111175), received between May 30, 2019 and Jan 22, 2020 — classified as 12 malfunctions.

The most frequently reported specific device problem is “Break” (12 reports).

Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. What reports can and can't tell you · How this data works · Data updated Oct 18, 2026.

Most reported problems

Recent adverse event reports

The 12 most recent of 12 reports, in the reporter's own words as published by the FDA.

• MalfunctionJan 22, 2020Break; Break

  CER #1 OF 3: (B)(4). CER #2 OF 3: (B)(4). CER #3 OF 3: (B)(4). THIS MORNING I LOOKED AT FEW OF THESE LATIS CATHETERS (UNOPENED FROM THE SAME COMPLAINT LOT (1312586) THAT WERE ALSO RETURNED FROM THE SAME HOSPITAL. I LOOKED AT 4 OF THEM AND THEY ALL SEEMED TO HAVE THE SAME PROBLEM. IT TOO BRITTLE AND KINKS EASILY. ONE OF THEM BROKE WHEN I ATTEMPTED TO REMOVE IT OUT OF THE PACKAGE. I STILL HAVE FEW UNOPENED UNITS THAT I CAN SEND TO YOUR TEAM IF YOUR ENGINEERING TEAM WANTS TO EVALUATE THEM. ADDITIONAL INFORMATION RECEIVED VIA EMAIL ON 15OCT2019 FROM QUALITY CONTROL ENG: IN MY COMPLAINT SYSTEM, THEY ARE ALREADY REGISTERED AS COMPLAINT (B)(4). THE ONLY NEW INFORMATION IS THAT WHEN I TESTED FEW UNOPENED UNITS (FROM THE SAME COMPLAINT LOT#) THAT WERE ALSO RETURNED FROM THE CUSTOMER ON SEPT 19, I REALIZED THEY WERE ALSO BRITTLE. ADDITIONAL INFORMATION RECEIVED VIA EMAIL ON 17OCT2019 FROM QUALITY CONTROL ENG: I HAVE 7 UNITS FROM LOT#1312586 REF A4GW6 THAT I CAN RETURN. THREE UNITS ARE OPENED UNITS THAT BROKE WHEN REMOVED FROM THE PACKAGE. REMAINING 4 ARE STILL SEALED INSIDE ITS PACKAGING. ADDITIONAL INFORMATION RECEIVED VIA EMAIL ON 31OCT2019 FROM QUALITY CONTROL ENG: PLEASE NOTE I HAVE ONLY

  Patient problems: No Patient Involvement

  MAUDE report 9619477 ↗
• MalfunctionJan 22, 2020Break; Break

  PROCEDURE PERFORMED: NA. CER #1 OF 3: (B)(4). CER #2 OF 3: (B)(4). CER #3 OF 3: (B)(4). THIS MORNING I LOOKED AT FEW OF THESE LATIS CATHETERS (UNOPENED FROM THE SAME COMPLAINT LOT ((B)(4)) THAT WERE ALSO RETURNED FROM THE SAME HOSPITAL. I LOOKED AT 4 OF THEM AND THEY ALL SEEMED TO HAVE THE SAME PROBLEM. IT TOO BRITTLE AND KINKS EASILY. ONE OF THEM BROKE WHEN I ATTEMPTED TO REMOVE IT OUT OF THE PACKAGE. I STILL HAVE FEW UNOPENED UNITS THAT I CAN SEND TO YOUR TEAM IF YOUR ENGINEERING TEAM WANTS TO EVALUATE THEM. ADDITIONAL INFORMATION RECEIVED VIA EMAIL ON 15OCT2019 FROM QUALITY CONTROL ENG: IN MY COMPLAINT SYSTEM, THEY ARE ALREADY REGISTERED AS COMPLAINT (B)(4). THE ONLY NEW INFORMATION IS THAT WHEN I TESTED FEW UNOPENED UNITS (FROM THE SAME COMPLAINT LOT#) THAT WERE ALSO RETURNED FROM THE CUSTOMER ON SEPT 19, I REALIZED THEY WERE ALSO BRITTLE. ADDITIONAL INFORMATION RECEIVED VIA EMAIL ON 17OCT2019 FROM QUALITY CONTROL ENG: I HAVE 7 UNITS FROM LOT#1312586 REF A4GW6 THAT I CAN RETURN. THREE UNITS ARE OPENED UNITS THAT BROKE WHEN REMOVED FROM THE PACKAGE. REMAINING 4 ARE STILL SEALED INSIDE ITS PACKAGING. ADDITIONAL INFORMATION RECEIVED VIA EMAIL ON 31OCT2019 FROM QUALITY CONTROL ENG:

  Patient problems: No Patient Involvement

  MAUDE report 9619472 ↗
• MalfunctionJan 22, 2020Break; Break

  CER #1 OF 3: (B)(4). CER #2 OF 3: (B)(4). CER #3 OF 3: (B)(4). THIS MORNING I LOOKED AT FEW OF THESE LATIS CATHETERS (UNOPENED FROM THE SAME COMPLAINT LOT (1312586) THAT WERE ALSO RETURNED FROM THE SAME HOSPITAL. I LOOKED AT 4 OF THEM AND THEY ALL SEEMED TO HAVE THE SAME PROBLEM. IT TOO BRITTLE AND KINKS EASILY. ONE OF THEM BROKE WHEN I ATTEMPTED TO REMOVE IT OUT OF THE PACKAGE. I STILL HAVE FEW UNOPENED UNITS THAT I CAN SEND TO YOUR TEAM IF YOUR ENGINEERING TEAM WANTS TO EVALUATE THEM. ADDITIONAL INFORMATION RECEIVED VIA EMAIL ON 15OCT2019 FROM QUALITY CONTROL ENG: IN MY COMPLAINT SYSTEM, THEY ARE ALREADY REGISTERED AS COMPLAINT (B)(4). THE ONLY NEW INFORMATION IS THAT WHEN I TESTED FEW UNOPENED UNITS (FROM THE SAME COMPLAINT LOT#) THAT WERE ALSO RETURNED FROM THE CUSTOMER ON SEPT 19, I REALIZED THEY WERE ALSO BRITTLE. ADDITIONAL INFORMATION RECEIVED VIA EMAIL ON 17OCT2019 FROM QUALITY CONTROL ENG: I HAVE 7 UNITS FROM LOT#1312586 REF A4GW6 THAT I CAN RETURN. THREE UNITS ARE OPENED UNITS THAT BROKE WHEN REMOVED FROM THE PACKAGE. REMAINING 4 ARE STILL SEALED INSIDE ITS PACKAGING. ADDITIONAL INFORMATION RECEIVED VIA EMAIL ON 31OCT2019 FROM QUALITY CONTROL ENG: PLEASE NOTE I HAVE ONLY

  Patient problems: No Patient Involvement

  MAUDE report 9619468 ↗
• MalfunctionJan 22, 2020Break; Break

  CER 1 OF 5: (B)(4). CER 2 OF 5: (B)(4). CER 3 OF 5: (B)(4). CER 4 OF 5: (B)(4). (ADDITIONAL CER CREATED ON 26NOV2019 TO LOG THE ADDITIONAL DAMAGED DEVICE RECEIVED). CER 5 OF 5: (B)(4).(ADDITIONAL CER CREATED ON 10JAN2020 FOR THE TIP FRACTURE OF THE UNDAMAGED DEVICE). THIS MORNING I LOOKED AT FEW OF THESE LATIS CATHETERS (UNOPENED FROM THE SAME COMPLAINT LOT (1312586) THAT WERE ALSO RETURNED FROM THE SAME HOSPITAL. I LOOKED AT 4 OF THEM AND THEY ALL SEEMED TO HAVE THE SAME PROBLEM. IT TOO BRITTLE AND KINKS EASILY. ONE OF THEM BROKE WHEN I ATTEMPTED TO REMOVE IT OUT OF THE PACKAGE. I STILL HAVE FEW UNOPENED UNITS THAT I CAN SEND TO YOUR TEAM IF YOUR ENGINEERING TEAM WANTS TO EVALUATE THEM. ADDITIONAL INFORMATION RECEIVED VIA EMAIL ON 15OCT2019 FROM QUALITY CONTROL ENG: THE ONLY NEW INFORMATION IS THAT WHEN I TESTED FEW UNOPENED UNITS (FROM THE SAME COMPLAINT LOT#) THAT WERE ALSO RETURNED FROM THE CUSTOMER ON SEPT 19, I REALIZED THEY WERE ALSO BRITTLE. ADDITIONAL INFORMATION RECEIVED VIA EMAIL ON 17OCT2019 FROM QUALITY CONTROL ENG: I HAVE 7 UNITS FROM LOT#1312586 REF A4GW6 THAT I CAN RETURN. THREE UNITS ARE OPENED UNITS THAT BROKE WHEN REMOVED FROM THE PACKAGE. REMAINING 4 ARE STILL S

  Patient problems: No Patient Involvement

  MAUDE report 9619175 ↗
• MalfunctionDec 6, 2019Break; Break

  PROCEDURE PERFORMED: NA. CER 1 OF 5: 2019-002503 CER 2 OF 5: 2019-002519 CER 3 OF 5: 2019-002520 CER 4 OF 5: 2019-002811 (ADDITIONAL CER CREATED ON 26NOV2019 TO LOG THE ADDITIONAL DAMAGED DEVICE RECEIVED) CER 5 OF 5: 2020-000089 (ADDITIONAL CER CREATED ON 10JAN2020 FOR THE TIP FRACTURE OF THE UNDAMAGED DEVICE). THIS MORNING I LOOKED AT FEW OF THESE LATIS CATHETERS (UNOPENED FROM THE SAME COMPLAINT LOT (1312586) THAT WERE ALSO RETURNED FROM THE SAME HOSPITAL. I LOOKED AT 4 OF THEM AND THEY ALL SEEMED TO HAVE THE SAME PROBLEM. IT TOO BRITTLE AND KINKS EASILY. ONE OF THEM BROKE WHEN I ATTEMPTED TO REMOVE IT OUT OF THE PACKAGE. I STILL HAVE FEW UNOPENED UNITS THAT I CAN SEND TO YOUR TEAM IF YOUR ENGINEERING TEAM WANTS TO EVALUATE THEM. ADDITIONAL INFORMATION RECEIVED VIA EMAIL ON 15OCT2019 FROM QUALITY CONTROL ENG: THE ONLY NEW INFORMATION IS THAT WHEN I TESTED FEW UNOPENED UNITS (FROM THE SAME COMPLAINT LOT#) THAT WERE ALSO RETURNED FROM THE CUSTOMER ON SEPT 19, I REALIZED THEY WERE ALSO BRITTLE. ADDITIONAL INFORMATION RECEIVED VIA EMAIL ON 17OCT2019 FROM QUALITY CONTROL ENG: I HAVE 7 UNITS FROM LOT#1312586 REF A4GW6 THAT I CAN RETURN. THREE UNITS ARE OPENED UNITS THAT BROKE WHEN REMO

  Patient problems: No Patient Involvement

  MAUDE report 9434384 ↗
• MalfunctionOct 18, 2019Break; Break

  PROCEDURE PERFORMED: NA. CER 1 OF 5: 2019-002503 CER 2 OF 5: 2019-002519 CER 3 OF 5: 2019-002520 CER 4 OF 5: 2019-002811 (ADDITIONAL CER CREATED ON 26NOV2019 TO LOG THE ADDITIONAL DAMAGED DEVICE RECEIVED). CER 5 OF 5: 2020-000089 (ADDITIONAL CER CREATED ON 10JAN2020 FOR THE TIP FRACTURE OF THE UNDAMAGED DEVICE). THIS MORNING I LOOKED AT FEW OF THESE LATIS CATHETERS (UNOPENED FROM THE SAME COMPLAINT LOT (1312586) THAT WERE ALSO RETURNED FROM THE SAME HOSPITAL. I LOOKED AT 4 OF THEM AND THEY ALL SEEMED TO HAVE THE SAME PROBLEM. IT TOO BRITTLE AND KINKS EASILY. ONE OF THEM BROKE WHEN I ATTEMPTED TO REMOVE IT OUT OF THE PACKAGE. I STILL HAVE FEW UNOPENED UNITS THAT I CAN SEND TO YOUR TEAM IF YOUR ENGINEERING TEAM WANTS TO EVALUATE THEM. ADDITIONAL INFORMATION RECEIVED VIA EMAIL ON 15OCT2019 FROM QUALITY CONTROL ENG: THE ONLY NEW INFORMATION IS THAT WHEN I TESTED FEW UNOPENED UNITS (FROM THE SAME COMPLAINT LOT#) THAT WERE ALSO RETURNED FROM THE CUSTOMER ON SEPT 19, I REALIZED THEY WERE ALSO BRITTLE. ADDITIONAL INFORMATION RECEIVED VIA EMAIL ON 17OCT2019 FROM QUALITY CONTROL ENG: I HAVE 7 UNITS FROM LOT#1312586 REF A4GW6 THAT I CAN RETURN. THREE UNITS ARE OPENED UNITS THAT BROKE WHEN REM

  Patient problems: No Patient Involvement

  MAUDE report 9211480 ↗
• MalfunctionOct 18, 2019Break; Break

  PROCEDURE PERFORMED: NA CER (B)(4) OF (B)(4) : (B)(4) CER (B)(4) OF (B)(4) : (B)(4) CER (B)(4) OF (B)(4) : (B)(4) CER (B)(4) OF (B)(4) : (B)(4) (ADDITIONAL CER CREATED ON (B)(6)2019 TO LOG THE ADDITIONAL DAMAGED DEVICE RECEIVED) CER (B)(4) OF (B)(4) : (B)(4) (ADDITIONAL CER CREATED ON (B)(6)2020 FOR THE TIP FRACTURE OF THE UNDAMAGED DEVICE) THIS MORNING I LOOKED AT FEW OF THESE LATIS CATHETERS (UNOPENED FROM THE SAME COMPLAINT LOT (1312586) THAT WERE ALSO RETURNED FROM THE SAME HOSPITAL. I LOOKED AT 4 OF THEM AND THEY ALL SEEMED TO HAVE THE SAME PROBLEM. IT TOO BRITTLE AND KINKS EASILY. ONE OF THEM BROKE WHEN I ATTEMPTED TO REMOVE IT OUT OF THE PACKAGE. I STILL HAVE FEW UNOPENED UNITS THAT I CAN SEND TO YOUR TEAM IF YOUR ENGINEERING TEAM WANTS TO EVALUATE THEM. ADDITIONAL INFORMATION RECEIVED VIA EMAIL ON 15OCT2019 FROM QUALITY CONTROL ENG: THE ONLY NEW INFORMATION IS THAT WHEN I TESTED FEW UNOPENED UNITS (FROM THE SAME COMPLAINT LOT#) THAT WERE ALSO RETURNED FROM THE CUSTOMER ON(B)(6) , I REALIZED THEY WERE ALSO BRITTLE. ADDITIONAL INFORMATION RECEIVED VIA EMAIL ON (B)(6)2019 FROM QUALITY CONTROL ENG: I HAVE 7 UNITS FROM LOT#1312586 REF A4GW6 THAT I CAN RETURN. THREE UNITS ARE OPE

  Patient problems: No Patient Involvement

  MAUDE report 9211479 ↗
• MalfunctionOct 18, 2019Break; Break

  PROCEDURE PERFORMED: NA. CER 1 OF 5: (B)(4). CER 2 OF 5: (B)(4). CER 3 OF 5: (B)(4). CER 4 OF 5: (B)(4) (ADDITIONAL CER CREATED ON 26NOV2019 TO LOG THE ADDITIONAL DAMAGED DEVICE RECEIVED). CER 5 OF 5: (B)(4) (ADDITIONAL CER CREATED ON 10JAN2020 FOR THE TIP FRACTURE OF THE UNDAMAGED DEVICE). THIS MORNING I LOOKED AT FEW OF THESE LATIS CATHETERS (UNOPENED FROM THE SAME COMPLAINT LOT (1312586) THAT WERE ALSO RETURNED FROM THE SAME HOSPITAL. I LOOKED AT 4 OF THEM AND THEY ALL SEEMED TO HAVE THE SAME PROBLEM. IT TOO BRITTLE AND KINKS EASILY. ONE OF THEM BROKE WHEN I ATTEMPTED TO REMOVE IT OUT OF THE PACKAGE. I STILL HAVE FEW UNOPENED UNITS THAT I CAN SEND TO YOUR TEAM IF YOUR ENGINEERING TEAM WANTS TO EVALUATE THEM. ADDITIONAL INFORMATION RECEIVED VIA EMAIL ON 15OCT2019 FROM QUALITY CONTROL ENG: THE ONLY NEW INFORMATION IS THAT WHEN I TESTED FEW UNOPENED UNITS (FROM THE SAME COMPLAINT LOT#) THAT WERE ALSO RETURNED FROM THE CUSTOMER ON SEPT 19, I REALIZED THEY WERE ALSO BRITTLE. ADDITIONAL INFORMATION RECEIVED VIA EMAIL ON 17OCT2019 FROM QUALITY CONTROL ENG: I HAVE 7 UNITS FROM LOT#1312586 REF A4GW6 THAT I CAN RETURN. THREE UNITS ARE OPENED UNITS THAT BROKE WHEN REMOVED FROM THE PACKAGE.

  Patient problems: No Patient Involvement

  MAUDE report 9211396 ↗
• MalfunctionSep 5, 2019Break; Break

  PROCEDURE PERFORMED: UNK. THE FIRST INSTANCE WAS WHEN THE SISTER REMOVED THE CATHETER FROM THE CONTAINER AND FLUSHED IT, WHEN SHE TRIED TO INTRODUCE A TERUMO HYDROPHILIC GUIDEWIRE THE CATHETER SNAPPED AT THE POINT WHERE THE WHITE AND BLUE MEET, AND THEN ALSO SNAPPED OFF IN THE MIDDLE OF THE CATHETER WHEN SHE WANTED TO PLACE IT IN A BOWL WITH SALINE IN. THE SECOND CASE WAS THAT THE BALLOON DID NOT INFLATE AT ALL. THEY REMOVED IT FROM THE CONTAINER, FLUSHED IT AND INFLATED THE BALLOON TO SEE IF IT WAS WORKING, IT DIDN¿T INFLATE. THIRD INSTANCE WAS THAT THE CATHETER BROKE AS SOON AS THEY REMOVED IT FROM THE CASING. WAITING ON INFORMATION, WHAT WAS WRONG WITH THE 4TH CATHETER." ADDITIONAL INFORMATION RECEIVED VIA EMAIL FROM QUALITY PROCESS ENGINEER ON MONDAY, 6MAY2019 "BASED ON THE INCIDENT REPORT, IT APPEARS THAT ALL OF THE INCIDENTS OCCURRED THE SAME DAY (B)(6) 2019 WITH THE SAME SURGEON AND ALL INCIDENTS ARE RELATED TO THE SAME LOT NUMBER. I DO NOT HAVE INFORMATION ON THE FOURTH INCIDENT AT THIS TIME. I WILL FORWARD YOU WITH THE REPORT ONCE I HEAR BACK FROM THE DISTRIBUTOR IN (B)(4)." ADDITIONAL INFORMATION RECEIVED VIA EMAIL FROM QUALITY PROCESS ENGINEER ON MONDAY, 14AUG2019: PHOTO

  Patient problems: No Patient Involvement

  MAUDE report 8966977 ↗
• MalfunctionAug 1, 2019Break; Break

  PROCEDURE PERFORMED: UNK. "THE FIRST INSTANCE WAS WHEN THE SISTER REMOVED THE CATHETER FROM THE CONTAINER AND FLUSHED IT, WHEN SHE TRIED TO INTRODUCE A TERUMO HYDROPHILIC GUIDEWIRE THE CATHETER SNAPPED AT THE POINT WHERE THE WHITE AND BLUE MEET, AND THEN ALSO SNAPPED OFF IN THE MIDDLE OF THE CATHETER WHEN SHE WANTED TO PLACE IT IN A BOWL WITH SALINE IN THE SECOND CASE WAS THAT THE BALLOON DID NOT INFLATE AT ALL. THEY REMOVED IT FROM THE CONTAINER, FLUSHED IT AND INFLATED THE BALLOON TO SEE IF IT WAS WORKING, IT DIDN¿T INFLATE. THIRD INSTANCE WAS THAT THE CATHETER BROKE AS SOON AS THEY REMOVED IT FROM THE CASING. WAITING ON INFORMATION, WHAT WAS WRONG WITH THE 4TH CATHETER." ADDITIONAL INFORMATION RECEIVED VIA EMAIL FROM QUALITY PROCESS ENGINEER ON MONDAY, 6MAY2019 "BASED ON THE INCIDENT REPORT, IT APPEARS THAT ALL OF THE INCIDENTS OCCURRED THE SAME DAY 4/24/2019 WITH THE SAME SURGEON AND ALL INIDENTS ARE RELATED TO THE SAME LOT NUMBER. I DO NOT HAVE INFORMATION ON THE FOURTH INCIDENT AT THIS TIME. I WILL FORWARD YOU WITH THE REPORT ONCE I HEAR BACK FROM THE DISTRIBUTOR IN SOUTH AFRICA." PATIENT STATUS: PATIENT NOT INVOLVED. TYPE OF INTERVENTION: NA.

  Patient problems: No Patient Involvement

  MAUDE report 8852903 ↗
• MalfunctionMay 30, 2019Break; Break

  PROCEDURE PERFORMED: UNK. THE FIRST INSTANCE WAS WHEN THE SISTER REMOVED THE CATHETER FROM THE CONTAINER AND FLUSHED IT, WHEN SHE TRIED TO INTRODUCE A TERUMO HYDROPHILIC GUIDEWIRE THE CATHETER SNAPPED AT THE POINT WHERE THE WHITE AND BLUE MEET, AND THEN ALSO SNAPPED OFF IN THE MIDDLE OF THE CATHETER WHEN SHE WANTED TO PLACE IT IN A BOWL WITH SALINE IN THE SECOND CASE WAS THAT THE BALLOON DID NOT INFLATE AT ALL. THEY REMOVED IT FROM THE CONTAINER, FLUSHED IT AND INFLATED THE BALLOON TO SEE IF IT WAS WORKING, IT DIDN¿T INFLATE. THIRD INSTANCE WAS THAT THE CATHETER BROKE AS SOON AS THEY REMOVED IT FROM THE CASING. WAITING ON INFORMATION, WHAT WAS WRONG WITH THE 4TH CATHETER." ADDITIONAL INFORMATION RECEIVED VIA EMAIL FROM QUALITY PROCESS ENGINEER ON MONDAY, 6MAY2019 "BASED ON THE INCIDENT REPORT, IT APPEARS THAT ALL OF THE INCIDENTS OCCURRED THE SAME DAY 4/24/2019 WITH THE SAME SURGEON AND ALL INIDENTS ARE RELATED TO THE SAME LOT NUMBER. I DO NOT HAVE INFORMATION ON THE FOURTH INCIDENT AT THIS TIME. I WILL FORWARD YOU WITH THE REPORT ONCE I HEAR BACK FROM THE DISTRIBUTOR IN SOUTH AFRICA." PATIENT STATUS: PATIENT NOT INVOLVED. TYPE OF INTERVENTION: NA.

  Patient problems: No Patient Involvement

  MAUDE report 8656554 ↗
• MalfunctionMay 30, 2019Break; Break

  PROCEDURE PERFORMED: UNK. THE FIRST INSTANCE WAS WHEN THE SISTER REMOVED THE CATHETER FROM THE CONTAINER AND FLUSHED IT, WHEN SHE TRIED TO INTRODUCE A TERUMO HYDROPHILIC GUIDEWIRE THE CATHETER SNAPPED AT THE POINT WHERE THE WHITE AND BLUE MEET, AND THEN ALSO SNAPPED OFF IN THE MIDDLE OF THE CATHETER WHEN SHE WANTED TO PLACE IT IN A BOWL WITH SALINE IN. THE SECOND CASE WAS THAT THE BALLOON DID NOT INFLATE AT ALL. THEY REMOVED IT FROM THE CONTAINER, FLUSHED IT AND INFLATED THE BALLOON TO SEE IF IT WAS WORKING, IT DIDN¿T INFLATE. THIRD INSTANCE WAS THAT THE CATHETER BROKE AS SOON AS THEY REMOVED IT FROM THE CASING. WAITING ON INFORMATION, WHAT WAS WRONG WITH THE 4TH CATHETER." ADDITIONAL INFORMATION RECEIVED VIA EMAIL FROM QUALITY PROCESS ENGINEER ON MONDAY, 6MAY2019. "BASED ON THE INCIDENT REPORT, IT APPEARS THAT ALL OF THE INCIDENTS OCCURRED THE SAME DAY (B)(6) 2019 WITH THE SAME SURGEON AND ALL INCIDENTS ARE RELATED TO THE SAME LOT NUMBER. I DO NOT HAVE INFORMATION ON THE FOURTH INCIDENT AT THIS TIME. I WILL FORWARD YOU WITH THE REPORT ONCE I HEAR BACK FROM THE DISTRIBUTOR IN SOUTH AFRICA." PATIENT STATUS: PATIENT NOT INVOLVED. TYPE OF INTERVENTION: NA.

  Patient problems: No Patient Involvement

  MAUDE report 8656553 ↗