MAUDE Adverse Event Report: COOK PEEL-AWAY; INTRODUCER, CATHETER

Model Number G08543

Device Problems Positioning Failure (1158); Difficult to Insert (1316)

Patient Problem Insufficient Information (4580)

Event Date 01/08/2016

Event Type  malfunction  

Event Description

On (b)(6) 2016, new implant of accolade procedure was performed.Recommended sheath is 6f, therefore they used micropuncture 6f sheah(c- pli-6.0.18-mp) peelaway introducer set for the procedure.However, it was unable to insert the lead when they attempted to insert the lead.They used 2 leads, but these 2 leads were unable to be inserted.The procedure was completed with micropuncture 8f sheath.6f sheath is recommended, but it could not pass through.Dr.Requested an detailed investigation.Physician: dr.(b)(6).Hospital: (b)(6) hospital.This report reflects information received by fda in the form of a notification per 803.22 (b)(2).

• Brand Name: PEEL-AWAY
• Type of Device: INTRODUCER, CATHETER
• Manufacturer (Section D): COOK
• MDR Report Key: 17528916
• MDR Text Key: 321366664
• Report Number: MW5135845
• Device Sequence Number: 1
• Product Code: DYB
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 06/20/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/12/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: No
• Device Model Number: G08543
• Patient Sequence Number: 1