Micropuncture G47949Recalls & reported problems

Summary

The FDA's MAUDE database contains 9 adverse event reports that list this exact device (DI 00827002479494), received between May 6, 2016 and Sep 9, 2024 — classified as 7 injuries, 2 malfunctions.

The most frequently reported specific device problem is “Material Separation” (6 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 16, 2026.

Most reported problems

Recent adverse event reports

The 9 most recent of 9 reports, in the reporter's own words as published by the FDA.

• InjurySep 9, 2024Unraveled Material; Unraveled Material

  ADDITIONAL INFORMATION WAS RECEIVED (B)(6) 2024. THE USER REPORTEDLY CHANGED THE ANGLE OF THE NEEDLE AS THE WIRE WAS PULLED BACK, CAUSING THE WIRE TO CATCH ON THE NEEDLE AND SUBSEQUENTLY UNRAVEL. THE TIP OF THE WIRE DID NOT SEPARATE, AND THERE WERE NO ADVERSE EFFECTS TO THE PATIENT. NO FURTHER INFORMATION WILL BE PROVIDED BY THE CUSTOMER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20170069 ↗
• InjuryMar 25, 2022Break; Break

  AS REPORTED, DURING A FEMORAL ANGIOGRAM, THE WIRE INCLUDED IN A MICROPUNCTURE TRANSITIONAL ACCESS SET SEPARATED. THE PATIENT WAS DESCRIBED AS "LARGE" AND ACCESS WAS DIFFICULT. THE WIRE WAS PASSED THROUGH THE ENTRY NEEDLE THREE TIMES PRIOR TO SEPARATING IN THE PATIENT. AN IMAGE PROVIDED BY THE CUSTOMER SHOWS A WIRE FRAGMENT WITHIN THE GROIN, ABOVE THE FEMORAL HEAD. THE PATIENT WAS THEN PLACED UNDER GENERAL ANESTHESIA, AND AN OPEN PROCEDURE INVOLVING A FEMORAL CUT-DOWN WAS PERFORMED TO SUCCESSFULLY RETRIEVE THE SEPARATED PORTION OF THE WIRE. THE PATIENT IS REPORTEDLY DOING WELL.

  Patient problems: Foreign Body In Patient

  MAUDE report 13904978 ↗
• InjuryDec 21, 2020Material Separation; Material Separation

  NO NEW PATIENT OR EVENT INFORMATION TO REPORT.

  Patient problems: No Clinical Signs, Symptoms or Conditions; No Consequences Or Impact To Patient

  MAUDE report 11045650 ↗
• MalfunctionDec 9, 2020Material Separation; Material Separation

  NO NEW PATIENT OR EVENT INFORMATION TO REPORT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10976896 ↗
• InjurySep 14, 2017Break; Break

  A MICROPUNCTURE TRANSITIONLESS ACCESS SET WAS BEING USED IN AN ABLATION. A VOLUNTARY MEDWATCH (MW5071744) STATED THAT DURING RADIOFREQUENCY ABLATION OF THE LEFT GREAT SAPHENOUS VEIN, THE END OF THE GUIDEWIRE (A 2IN FLEXIBLE PORTION) BROKE OFF INSIDE THE VEIN. FOLLOWING AN X-RAY, THE ENTIRE PIECE WAS REMOVED AND PROCEDURE WAS COMPLETED SUCCESSFULLY. ACCORDING TO THE REPORTER, NO OTHER ADVERSE EFFECTS WERE EXPERIENCED DUE TO THIS OCCURRENCE.

  Patient problems: Device Embedded In Tissue or Plaque; No Code Available

  MAUDE report 6866025 ↗
• MalfunctionJul 17, 2017Material Separation; Failure to Advance; Physical Resistance

  THE PHYSICIAN PLACED THE NEEDLE TO ACCESS THE ARTERY. WHEN THE PHYSICIAN ATTEMPTED TO PUT THE MICRO PUNCTURE WIRE INTO THE NEEDLE, THE WIRE WOULD NOT ADVANCE AND MET RESISTANCE. THE PHYSICIAN ATTEMPTED TO PULL BACK THE WIRE AND RESISTANCE WAS FELT AS WELL. BOTH THE WIRE AND THE NEEDLE WERE WITHDRAWN, AND A NEW DEVICE WAS OPENED AND USED TO COMPLETE THE PROCEDURE. THE DEVICE WAS RETURNED, AND AN EXAMINATION REVEALED THAT THE DISTAL WELD CONNECTION HAD SEPARATED FROM THE MANDRIL WIRE, CAUSING ELONGATION AND COMPLETE SEPARATION OF A COIL SEGMENT. A SECTION OF THE DEVICE DID NOT REMAIN INSIDE THE PATIENT'S BODY. THE PATIENT DID NOT REQUIRE ANY ADDITIONAL PROCEDURES DUE TO THIS OCCURRENCE. ACCORDING TO THE INITIAL REPORTER, THE PATIENT DID NOT EXPERIENCE ANY ADVERSE EFFECTS DUE TO THIS OCCURRENCE.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6716842 ↗
• InjuryMar 30, 2017Material Separation; Appropriate Device Problem Term/Code Not Available; Material Separation; Appropriate Device Problem Term/Code Not Available

  DURING A PROCEDURE A WIRE WAS BEING PLACED THROUGH AN INTRODUCER INTO THE PATIENT. THE WIRE "SHREDDED" AGAINST THE INTRODUCER NEEDLE AND BROKE OFF INSIDE THE PATIENT. AT THIS TIME THE PATIENT REQUIRED AN OPEN PROCEDURE TO RETRIEVE THE WIRE. DURING THIS RETRIEVAL PROCEDURE, THE WIRE WAS SUCCESSFULLY REMOVED FROM THE PATIENT. ADDITIONAL INFORMATION ABOUT THE EVENT AND THE DEVICE WAS REQUESTED BUT NOT PROVIDED.

  Patient problems: Device Embedded In Tissue or Plaque

  MAUDE report 6446084 ↗
• InjuryJul 13, 2016Material Separation; Material Separation

  THE HANDLE OF THE DILATOR RIPPED OFF WHILE IT WAS STILL IN THE PATIENT. THE RIP OCCURRED OUTSIDE THE PATIENT. THIS MADE IT VERY DIFFICULT TO GET THE DILATOR THAT WAS INSIDE THE PATIENT. THE PROCEDURE WAS COMPLETED WITH THE COMPLAINT DEVICE AS THEY HAD ALREADY GAINED ACCESS BEFORE THE DIFFICULTY OCCURRED. A SECTION OF THE DEVICE DID NOT REMAIN INSIDE THE PATIENT'S BODY. THE PATIENT DID NOT REQUIRE ANY ADDITIONAL PROCEDURES DUE TO THIS OCCURRENCE. ACCORDING TO THE INITIAL REPORTER, THE PATIENT DID NOT EXPERIENCE ANY ADVERSE EFFECTS DUE TO THIS OCCURRENCE.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 5790144 ↗
• InjuryMay 6, 2016Material Separation; Material Separation

  PER VOLUNTARY REPORT MW5061023: THE INNER CATHETER OF THE MICROPUNCTURE SET SEPARATED, LEAVING HALF IN THE PATIENT. THE CATHETER WAS SNARED AND REMOVED. ADDITIONAL INFORMATION WAS PROVIDED STATING: THE PATIENT HAD A LARGE LEFT NECK TUMOR (METASTATIC STAGE 4 CA W/LUNG) THAT HAD PERSISTENT BLEEDING-OOZING. THE PATIENT HAD 2 PRIOR EMBOLIZATIONS OF CAROTID ARTERY AND WAS STABLE, THEN IT BEGAN OOZING AGAIN. IT WAS NECESSARY TO SACRIFICE THE LEFT VERTEBRAL ARTERY. DURING THE RIGHT GROIN PUNCTURE, THE MICROPUNCTURE "GOT CAUGHT UP IN RIGHT GROIN AND SHEARED OFF 4 INCHES OF CATHETER WITH THE DISTAL END STILL REMAINING WITHIN THE VESSEL. THE LEFT GROIN WAS ACCESSED AND A GOOSENECK WAS USED TO SNARE THE WIRE AND CATHETER AT THE ARTERIOTOMY SITE. PER VOLUNTARY REPORT MW5061023: DISTAL END STILL IN VESSEL. IT IS UNKNOWN IF THERE HAVE BEEN ANY ADVERSE EFFECTS AT THIS TIME. ADDITIONAL INFORMATION HAS BEEN REQUESTED BUT NOT YET PROVIDED BY THE REPORTER.

  Patient problems: Device Embedded In Tissue or Plaque

  MAUDE report 5636785 ↗