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 01/08/2018

Event Type  malfunction  

Event Description

During procedure, micropuncture needle wire got stuck in the needle tip.It was able to be removed in totality.No harm to patient.

• Brand Name: MICROPUNCTURE
• Type of Device: INTRODUCER, CATHETER
• Manufacturer (Section D): COOK INCORPORATED; 1100 w morgan st; spencer IN 47460
• MDR Report Key: 7258781
• MDR Text Key: 99543031
• Report Number: 7258781
• 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: 02/08/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/09/2018
• Is this a Product Problem Report?: Yes
• Device Operator: Physician
• Device Expiration Date: 11/21/2020
• Device Model Number: G48003
• Device Catalogue Number: MPIS-401-10.0-SC-NT-SST
• Device Lot Number: 8393541
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 02/08/2018
• Event Location: Hospital
• Date Report to Manufacturer: 02/08/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 73 YR
• Patient Weight: 65