MAUDE Adverse Event Report: COOK INCORPORATED MICROPUNCTURE; INTRODUCER, CATHETER

Model Number G47940

Device Problem Material Fragmentation (1261)

Patient Problem Device Embedded In Tissue or Plaque (3165)

Event Date 08/05/2020

Event Type  malfunction  

Event Description

Patient was having a lower extremity angiogram.While accessing the groin, a piece of the wire from a cook micropuncture kit broke off in the patient's left groin.Doctor attempted to remove the piece of wire but was unsuccessful.It was felt that it created more risk for the patient to retrieve the wire than to let it stay in the groin.

• Brand Name: MICROPUNCTURE
• Type of Device: INTRODUCER, CATHETER
• Manufacturer (Section D): COOK INCORPORATED; 750 daniels way; bloomington IN 47404
• MDR Report Key: 10419608
• MDR Text Key: 203315231
• Report Number: 10419608
• Device Sequence Number: 1
• Product Code: DYB
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 08/11/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/18/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: G47940
• Device Catalogue Number: MPIS-401-SST
• Device Lot Number: 13139154
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 08/11/2020
• Event Location: Hospital
• Date Report to Manufacturer: 08/18/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 20075 DA