MAUDE Adverse Event Report: ABBOTT VASCULAR G4 STEERABLE GUIDING CATHETER; CATHETER, STEERABLE

Model Number SGC0701

Device Problem Peeled/Delaminated (1454)

Patient Problem No Patient Involvement (2645)

Event Date 12/01/2020

Event Type  malfunction  

Manufacturer Narrative

The device has been received.Investigation is not yet complete.A follow-up report will be submitted with all additional relevant information.

Event Description

This is filed to report peeled material.It was reported that during preparation of the steerable guide catheter (sgc), the dilator was inserted into the sgc, but it was noticed that a piece of the dilator had become frayed.The physician decided to not use the device and replace it.There was no clinically significant delay in the procedure.No additional information was provided.

Manufacturer Narrative

The returned device analysis was unable to confirm the reported peeled/delaminated dilator tip; however, it was observed there was irregular appearance of the slanted/cut dilator tip.A review of the lot history record revealed no manufacturing nonconformities issued to the reported lot.Additionally, a review of the complaint history identified no other incidents reported from this lot.A cause for the reported peeled/delaminated issue could not be determined.However, the investigation identified a potential product quality issue due to irregular appearance of the slanted/cut dilator.The issue is being addressed per internal operation procedures.Abbott vascular will continue to trend the performance of these devices.

• Brand Name: G4 STEERABLE GUIDING CATHETER
• Type of Device: CATHETER, STEERABLE
• Manufacturer (Section D): ABBOTT VASCULAR; 26531 ynez rd.; temecula CA 92591 4628
• MDR Report Key: 11065180
• MDR Text Key: 223602488
• Report Number: 2024168-2020-10886
• Device Sequence Number: 1
• Product Code: DRA
• UDI-Device Identifier: 08717648231025
• UDI-Public: 08717648231025
• Combination Product (y/n): N
• PMA/PMN Number: K190167
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup
• Report Date: 01/12/2021

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 Expiration Date: 10/15/2021
• Device Model Number: SGC0701
• Device Catalogue Number: SGC0701
• Device Lot Number: 01013U311
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/03/2020
• Initial Date Manufacturer Received: 12/01/2020
• Initial Date FDA Received: 12/23/2020
• Supplement Dates Manufacturer Received: 01/04/2021
• Supplement Dates FDA Received: 01/12/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1