MAUDE Adverse Event Report: COOK INC. MICROPUNCTURE INTRODUCER SET; INTRODUCER, CATHETER

Lot Number 14064137

Device Problems Break (1069); Entrapment of Device (1212)

Patient Problem Foreign Body In Patient (2687)

Event Date 07/20/2021

Event Type  malfunction  

Event Description

Patient presented to operating room for a left leg angioplasty.During procedure, as the guidewire was removed from the left groin puncture site, the wire fractured with a portion retained.Fda safety report id # (b)(4).

• Brand Name: MICROPUNCTURE INTRODUCER SET
• Type of Device: INTRODUCER, CATHETER
• Manufacturer (Section D): COOK INC. ; bloomington IN 47404
• MDR Report Key: 12217543
• MDR Text Key: 263418423
• Report Number: MW5102736
• Device Sequence Number: 1
• Product Code: DYB
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 07/21/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Lot Number: 14064137
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 07/22/2021
• Was Device Evaluated by Manufacturer?: No Information
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 88 YR
• Patient Weight: 76