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

Model Number G48003

Device Problem Sticking (1597)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 11/17/2017

Event Type  malfunction  

Event Description

During pacemaker implantation, the micropuncture introducer set is used for access.The wire became stuck in the needle and the physician had to remove the set and perform another stick.

• Brand Name: MICROPUNCTURE
• Type of Device: INTRODUCER, CATHETER
• Manufacturer (Section D): COOK INCORPORATED; 750 daniels way; bloomington IN 47404
• MDR Report Key: 7167154
• MDR Text Key: 96457257
• Report Number: 7167154
• 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: User Facility
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 12/28/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/05/2018
• Is this a Product Problem Report?: Yes
• Device Operator: Physician
• Device Expiration Date: 10/10/2020
• Device Model Number: G48003
• Device Catalogue Number: MPIS-401-10.0-SC-NT-SST
• Device Lot Number: 828147
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 12/28/2017
• Event Location: Hospital
• Date Report to Manufacturer: 12/28/2017
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 91 YR
• Patient Weight: 74