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

Model Number SGC0701

Device Problem Leak/Splash (1354)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 11/11/2020

Event Type  malfunction  

Manufacturer Narrative

The device is expected to be returned for evaluation.It has not yet been received.A follow up report will be submitted with all additional relevant information.The additional device referenced is filed under a separate medwatch report number.

Event Description

This is being filed to report the steerable guide catheter filling with air.It was reported that this was a mitraclip procedure to treat functional mitral regurgitation (mr) with a grade of 4.Three clips were implanted, reducing mr to 1.At the end of the procedure, when removing the last clip delivery system (cds), the tip of the clip introducer remained on the back of the steerable guide catheter (sgc).The sgc filled up with air and was removed quickly from the patient.No air entered the patient.There was no clinically significant delay in the procedure and no adverse patient effects.No additional information was provided.

Manufacturer Narrative

The returned device analysis confirmed the reported leak.Additionally, a kink was observed on steerable guide catheter (sgc) shaft and the silicone valve slit observed to be open and did not close.A review of the lot history record identified no manufacturing nonconformities issued to the reported lot that would have contributed to the reported event.Additionally, a review of the complaint history identified no similar incidents reported from this lot.Based on the investigation, the observed open slit appeared to be due to post-procedural condition.The reported leak appears to be due to the observed open silicone valve.A cause for kink on sgc shaft can not be determined.There is no indication of a product issue with respect to manufacture, design or labeling.

• 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: 11004411
• MDR Text Key: 223453834
• Report Number: 2024168-2020-10454
• 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,foreig
• Type of Report: Initial,Followup
• Report Date: 02/17/2021

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: 10/04/2021
• Device Model Number: SGC0701
• Device Catalogue Number: SGC0701
• Device Lot Number: 00928U922
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/15/2020
• Initial Date Manufacturer Received: 11/19/2020
• Initial Date FDA Received: 12/14/2020
• Supplement Dates Manufacturer Received: 01/25/2021
• Supplement Dates FDA Received: 02/17/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: 2 IMPLANTED MITRACLIPS.; CLIP DELIVERY SYSTEM.
• Patient Age: 76 YR