MAUDE Adverse Event Report: ABBOTT VASCULAR MITRACLIP SYSTEM STEERABLE GUIDE CATHETER VALVE REPAIR

Catalog Number SGC0302

Device Problems Positioning Failure (1158); Mechanical Jam (2983); Noise, Audible (3273)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 06/05/2020

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.

Event Description

This is filed to report inability to straighten tip. It was reported that this was a mitraclip procedure to treat functional mitral regurgitation (mr) with a grade of 4. The steerable guide catheter (sgc) was inserting into the groin when a loud noise was heard. The sgc was removed to examine the knobs. The sgc tip could not be straighten. The procedure continued with a new sgc. One clip was implanted, reducing mr to 1-2. There were no adverse patient effects and no clinically significant delay in the procedure. No additional information was provided.

• Brand Name: MITRACLIP SYSTEM STEERABLE GUIDE CATHETER
• Type of Device: VALVE REPAIR
• 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: 10174919
• MDR Text Key: 195889237
• Report Number: 2024168-2020-05182
• Device Sequence Number: 1
• Product Code: DRA
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K161985
• 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: 08/04/2020

1 Device was Involved in the Event

0 Patients were Involved in the Event:

• Date FDA Received: 06/19/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes

Device Operator

• Device Expiration Date: 08/08/2020
• Device Catalogue Number: SGC0302
• Device Lot Number: 90808U256
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/23/2020
• Is the Reporter a Health Professional?: Yes

Was the Report Sent to FDA?

• Event Location: No Information
• Date Manufacturer Received: 07/24/2020
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/09/2019
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial