Cook G09499Recalls & reported problems

Summary

The FDA's MAUDE database contains 11 adverse event reports that list this exact device (DI 00827002094994), received between Nov 9, 2017 and Nov 10, 2021 — classified as 4 injuries, 7 malfunctions.

The most frequently reported specific device problem is “Break” (3 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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 11 most recent of 11 reports, in the reporter's own words as published by the FDA.

• MalfunctionNov 10, 2021Device Contaminated During Manufacture or Shipping; Device Contaminated During Manufacture or Shipping

  IT WAS REPORTED A PIECE OF PLASTIC WAS FOUND WITHIN A DILATOR OF AN ULTRATHANE MAC-LOC LOCKING LOOP BILIARY DRAINAGE CATHETER. A GUIDEWIRE WAS UNABLE TO BE INTRODUCED THROUGH THE DILATOR AND BECAUSE THE DILATOR IS CLEAR, THE USER NOTED THE PLASTIC WITHIN THE LUMEN. ANOTHER PRODUCT WAS USED TO COMPLETE THE PROCEDURE. AS REPORTED, THE PATIENT DID NOT EXPERIENCE ANY ADVERSE EFFECTS OR REQUIRE ANY ADDITIONAL PROCEDURES DUE TO THIS OCCURRENCE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12790760 ↗
• MalfunctionFeb 28, 2020Device Contaminated During Manufacture or Shipping; Device Contaminated During Manufacture or Shipping

  NO ADDITIONAL INFORMATION REGARDING THE PATIENT AND/OR EVENT HAS BEEN RECEIVED SINCE THE PREVIOUS MEDWATCH REPORT WAS SENT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9770605 ↗
• MalfunctionSep 23, 2019Leak/Splash; Leak/Splash

  NO ADDITIONAL INFORMATION REGARDING THE PATIENT AND/OR EVENT HAS BEEN RECEIVED SINCE THE PREVIOUS MEDWATCH REPORT WAS SENT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9107003 ↗
• MalfunctionDec 4, 2018Device Contaminated During Manufacture or Shipping; Device Contaminated During Manufacture or Shipping

  IT WAS REPORTED FOREIGN MATTER WAS FOUND IN THE PACKAGING OF AN ULTRATHANE MAC-LOC LOCKING LOOP BILIARY DRAINAGE CATHETER OUTSIDE OF MANUFACTURER DISTRIBUTION. THE PRODUCT DID NOT MAKE PATIENT CONTACT OR AFFECT THE SCHEDULING OF ANY PROCEDURES.

  Patient problems: No Patient Involvement

  MAUDE report 8130396 ↗
• MalfunctionDec 20, 2017Break; Break

  THE INTERNATIONAL CUSTOMER REPORTED THAT, WHEN THE RADIOLOGIST ATTEMPTED TO LOCK THE ULTRATHANE MAC-LOC LOCKING LOOP BILIARY DRAINAGE CATHETER INTO PLACE FOLLOWING PLACEMENT OVER THE WIRE, THE LOCKING SUTURE SNAPPED AT THE HUB OF THE DEVICE. THE DEVICE HAD TO BE EXCHANGED FOR ANOTHER CATHETER. THE CUSTOMER CONFIRMED THAT NO PATIENT ADVERSE EVENTS OCCURRED AS A RESULT OF THE ISSUE. THE PROCEDURE WAS A BILIARY DRAINAGE CATHETER EXCHANGE. THE DEVICE IS REPORTEDLY AVAILABLE FOR RETURN; HOWEVER, AS OF THE DATE OF THIS REPORT, NO DEVICE HAS YET BEEN RECEIVED FOR EVALUATION. AS THIS CASE DID NOT INVOLVE THE SUTURE REMAINING IN THE BODY AND DID NOT REQUIRE A DIFFERENT PROCEDURE AT ANOTHER DATE, IT SHOULD NOT HAVE BEEN SUBMITTED AS REPORTABLE AND SHOULD NOT REFLECT A CHANGE TO COOK'S HANDLING OF SIMILAR COMPLAINTS. AS THIS CASE DID NOT INVOLVE THE SUTURE REMAINING IN THE BODY AND DID NOT REQUIRE A DIFFERENT PROCEDURE AT ANOTHER DATE, IT SHOULD NOT HAVE BEEN SUBMITTED AS REPORTABLE AND SHOULD NOT REFLECT A CHANGE TO COOK'S HANDLING OF SIMILAR COMPLAINTS.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7133076 ↗
• MalfunctionDec 20, 2017Break; Break

  THE INTERNATIONAL CUSTOMER REPORTED THAT, WHEN THE RADIOLOGIST ATTEMPTED TO LOCK THE ULTRATHANE MAC-LOC LOCKING LOOP BILIARY DRAINAGE CATHETER INTO PLACE FOLLOWING PLACEMENT OVER THE WIRE, THE LOCKING SUTURE SNAPPED AT THE HUB OF THE DEVICE. THE DEVICE HAD TO BE EXCHANGED FOR ANOTHER CATHETER. THE CUSTOMER CONFIRMED THAT NO PATIENT ADVERSE EVENTS OCCURRED AS A RESULT OF THE ISSUE. THE PROCEDURE WAS A BILIARY DRAINAGE CATHETER EXCHANGE. THE DEVICE IS REPORTEDLY AVAILABLE FOR RETURN; HOWEVER, AS OF THE DATE OF THIS REPORT, NO DEVICE HAS YET BEEN RECEIVED FOR EVALUATION. AS THIS CASE DID NOT INVOLVE THE SUTURE REMAINING IN THE BODY AND DID NOT REQUIRE A DIFFERENT PROCEDURE AT ANOTHER DATE, IT SHOULD NOT HAVE BEEN SUBMITTED AS REPORTABLE AND SHOULD NOT REFLECT A CHANGE TO COOK'S HANDLING OF SIMILAR COMPLAINTS. AS THIS CASE DID NOT INVOLVE THE SUTURE REMAINING IN THE BODY AND DID NOT REQUIRE A DIFFERENT PROCEDURE AT ANOTHER DATE, IT SHOULD NOT HAVE BEEN SUBMITTED AS REPORTABLE AND SHOULD NOT REFLECT A CHANGE TO COOK'S HANDLING OF SIMILAR COMPLAINTS.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7133073 ↗
• InjuryDec 12, 2017Fluid/Blood Leak; Fluid/Blood Leak

  THE CUSTOMER REPORTED THAT, AFTER PLACEMENT OF THE ULTRATHANE MAC-LOC LOCKING LOOP BILIARY DRAINAGE CATHETER BY THE PHYSICIAN, IT WAS NOTICED THAT THE DRAIN WAS LEAKING FROM THE HUB. THE LEAK WAS DISCOVERED WHEN THE PATIENT WAS BEING MOVED TO THEIR BED. THE PATIENT WAS RE-PREPPED, AND THE DRAIN WAS EXCHANGED FOR A NEW DEVICE IN ANOTHER PROCEDURE. THE COMPLAINT DEVICE WAS EMPLOYED IN A BILIARY INDICATION, AND WAS IN PLACE LESS THAN 1 HOUR. THE COMPLAINT DEVICE IS REPORTEDLY AVAILABLE FOR RETURN AND EVALUATION; HOWEVER, AS OF THE DATE OF THIS REPORT, NO DEVICE HAS YET BEEN RECEIVED.

  Patient problems: No Code Available

  MAUDE report 7107574 ↗
• InjuryDec 7, 2017Fluid/Blood Leak; Fluid/Blood Leak

  THE CUSTOMER REPORTED THAT THE IMPLANTED ULTRATHANE MAC-LOC LOCKING LOOP BILIARY DRAINAGE CATHETER WAS LEAKING FROM THE JUNCTION BETWEEN THE LUER LOCK PORTION OF THE DEVICE AND THE CATHETER MEET, WHERE THE TWO PIECES CAN BE SCREWED TOGETHER OR UNSCREWED. THE DEVICE WAS SUBSEQUENTLY REPLACED. THE DEVICE WAS BEING PLACED IN THE LIVER FOR A BILIARY DRAINAGE INDICATION. THE COMPLAINT DEVICE WAS IN PLACE FOR 37 DAYS PRIOR TO ITS REMOVAL. THE DEVICE HAS BEEN RECEIVED FOR EVALUATION; HOWEVER, AS OF THE DATE OF THIS REPORT, THE INVESTIGATION IS STILL PENDING.

  Patient problems: No Code Available

  MAUDE report 7098264 ↗
• InjuryNov 14, 2017Leak/Splash

  DURING A BILIARY DRAINAGE CATHETER PLACEMENT, THE PHYSICIAN PLACED A 12FR BILLIARY DRAINAGE CATHETER AND THE DEVICE LEAKED AT THE HUB. THE PHYSICIAN THEN PLACED A 14FR BILIARY DRAINAGE CATHETER WITH NO COMPLICATIONS.

  Patient problems: No Code Available

  MAUDE report 7028554 ↗
• MalfunctionNov 13, 2017Leak/Splash

  THE PATIENT HAD A 12FR BILIARY DRAINAGE TUBE PLACED UNDER GENERAL ANESTHESIA. THE TUBE WAS FLUSHED AND INJECTED WITH CONTRAST AND NO LEAK WAS SEEN. THE PATIENT WAS DISCHARGED. APPROXIMATELY 3 HOURS LATER THE PATIENT CALLED STATING THE TUBE WAS LEAKING. THE FACILITY REQUESTED THE PATIENT COME IN TO THE IMAGING DEPARTMENT. THE TUBE WAS EXAMINED BY THE LEAD TECH AND THE PHYSICIAN. THERE WAS AN OBVIOUS LEAK AT THE JUNCTION OF THE DRAINAGE TUBE AND MAC-LOC. THE PHYSICIAN WAS ABLE TO UNSCREW THE TUBE FROM THE MAC-LOC AND THREAD IT BACK ON PROPERLY. THE RETENTION FILAMENT WAS CUT TO ACCOMPLISH THIS. THE TUBE DID NOT LEAK AFTER THAT. ACCORDING TO THE INITIAL REPORTER, THE PATIENT DID NOT EXPERIENCE ANY ADVERSE EFFECTS DUE TO THIS OCCURRENCE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7025617 ↗
• InjuryNov 9, 2017Break

  THE COMPLAINANT REPORTED THAT THE LOCK SNAPPED ON THE DRAIN AFTER THE PROCEDURE AND AN ADDITIONAL PROCEDURE WAS PERFORMED TO INSERT A NEW LINE. THERE WERE NO REPORTS OF ANY SECTION OF THE DEVICE REMAINING INSIDE THE PATIENT'S BODY OR ANY ADDITIONAL PROCEDURES AS A RESULT OF THIS PRODUCT PROBLEM. ADDITIONALLY, THE INITIAL REPORTER NOTED THAT THE PATIENT DID NOT EXPERIENCE ANY ADVERSE EFFECTS AS A RESULT OF THIS PRODUCT PROBLEM.

  Patient problems: No Code Available

  MAUDE report 7014358 ↗