MAUDE Adverse Event Report: COOK INCORPORATED GUIDE WIRE COOK MEDICAL - MICROPUNCTURE INTRODUCER SET; INTRODUCER, CATHETER

Model Number MPIS-501-SST

Device Problem Break (1069)

Patient Problem Foreign Body In Patient (2687)

Event Date 06/02/2022

Event Type  Injury  

Event Description

Left upper extremity de-clot of arteriovenous fistula.Guide wire broke off inside patient resulting in foreign body.Per documentation there was no resistance or difficulty noted from the user.Fda safety report id# (b)(4).

• Brand Name: GUIDE WIRE COOK MEDICAL - MICROPUNCTURE INTRODUCER SET
• Type of Device: INTRODUCER, CATHETER
• Manufacturer (Section D): COOK INCORPORATED; bloomington IN 47404
• MDR Report Key: 14776232
• MDR Text Key: 294617549
• Report Number: MW5110420
• Device Sequence Number: 1
• Product Code: DYB
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date: 06/16/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/21/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: MPIS-501-SST
• Device Lot Number: 14527811
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 74 YR
• Patient Sex: Female
• Patient Weight: 57 KG
• Patient Ethnicity: Hispanic
• Patient Race: White