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

Catalog Number SGC0705

Device Problem Difficult to Remove (1528)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 10/19/2020

Event Type  malfunction  

Manufacturer Narrative

The device was returned. Investigation is not yet complete. A follow-up report will be submitted with all additional relevant information. The additional mitraclip device is filed under a separate medwatch report number.

Event Description

This is being filed to report the difficulty removing the clip delivery system into the steerable guide catheter. It was reported that this was a mitraclip procedure to treat degenerative mitral regurgitation (mr) with a grade of 4. One clip was successfully placed without issue. A second clip delivery system (cds) was advanced into the left atrium (la) when a fluttering tissue was noted on the clip on echo. Heparin was administered, and an attempt was made to remove the cds, however, resistance was met with the steerable guide catheter (sgc). Troubleshooting was performed however the cds could still not be retracted. The physician then decided to continue the procedure with the cds, and it was advanced to the mitral valve and deployed. A white foreign substance was noted attached to the tip of the cds once the clip detached from the delivery catheter (dc). The cds was removed and the procedure completed with the mr reduced to 1. There was no clinically significant delay in the procedure, and no adverse patient effects. No additional information was provided.

• Brand Name: G4 STEERABLE GUIDING CATHETER
• Type of Device: CATHETER, STEERABLE
• Manufacturer (Section D): ABBOTT VASCULAR; 26531 ynez rd.; temecula CA 92591 4628
• Manufacturer (Section G): ABBOTT VASCULAR, REG # 3005070406; 3885 bohannon drive; menlo park CA 94025
• Manufacturer Contact: lindsey bell ; 26531 ynez rd.; temecula, CA 92591-4628 ; 9519143996
• MDR Report Key: 10830216
• MDR Text Key: 216370495
• Report Number: 2024168-2020-09444
• Device Sequence Number: 1
• Product Code: DRA
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K190167
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig

Reporter Occupation

• Type of Report: Initial,Followup
• Report Date: 01/12/2021

1 Device was Involved in the Event

0 Patients were Involved in the Event:

• Date FDA Received: 11/12/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes

Device Operator

• Device Expiration Date: 07/17/2021
• Device Catalogue Number: SGC0705
• Device Lot Number: 00717U123
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/03/2020
• Is the Reporter a Health Professional?: Yes

Was the Report Sent to FDA?

• Event Location: No Information
• Date Manufacturer Received: 01/06/2021
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/18/2020
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial