MAUDE Adverse Event Report: ST. JUDE MEDICAL PEEL-AWAY INTRODUCER 14CM SHEATH INTRODUCER KIT, 6F; INTRODUCER, CATHETER

Model Number 405104

Device Problem Fracture (1260)

Patient Problems No Consequences Or Impact To Patient (2199); Device Embedded In Tissue or Plaque (3165)

Event Date 08/07/2020

Event Type  malfunction  

Manufacturer Narrative

The results of the investigation are inconclusive since the device was not returned for analysis.The device history record was reviewed to ensure that each manufacturing and inspection operation was performed.Based on the information received, the cause of the reported incident could not be conclusively determined.

Event Description

During the procedure, the sheath did not peel properly and a scalpel had to be used to peel the device.When peeling, the sheath split into several pieces and had to be removed from the patient.There were no consequences to the patient.

• Brand Name: PEEL-AWAY INTRODUCER 14CM SHEATH INTRODUCER KIT, 6F
• Type of Device: INTRODUCER, CATHETER
• Manufacturer (Section D): ST. JUDE MEDICAL; 5050 nathan lane north; plymouth MN 55442
• MDR Report Key: 10421451
• MDR Text Key: 203367601
• Report Number: 3005334138-2020-00358
• Device Sequence Number: 1
• Product Code: DYB
• UDI-Device Identifier: 05414734204088
• UDI-Public: 05414734204088
• Combination Product (y/n): N
• PMA/PMN Number: K894431
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 01/22/2021

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?: No
• Device Operator: Health Professional
• Device Expiration Date: 11/30/2022
• Device Model Number: 405104
• Device Catalogue Number: 405104
• Device Lot Number: 7313161
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 08/10/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1