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

Catalog Number SGC0302

Device Problems Break (1069); Positioning Failure (1158); Mechanical Jam (2983)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 11/25/2020

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 being filed to report the suspected cable break.It was reported that this was a mitraclip procedure to treat degenerative mitral regurgitation (mr) with a grade of 4+.Upon insertion into the anatomy, it was noted minus was unable to be applied to the steerable guide catheter (sgc) and the tip was unable to curve.A cable break was suspected.The device was removed and a new sgc was used and two clips were implanted, reducing mr to <1.There was no clinically significant delay in the procedure and no adverse patient effects.No additional information was provided.

Manufacturer Narrative

The device was investigated, and the returned device analysis confirmed the reported mechanical jam and positioning failure due to the observed cable break.A review of the lot history record identified no exception issued to the reported lot that would have resulted in this event.Additionally, a review of the complaint history identified no other complaint reported from this lot.All available information was investigated and a conclusive cause for the reported break could not be determined in this complaint.The reported mechanical jam and positioning failure were cascading effects of cable break.There is no indication of a product issue with respect to manufacture, design, or labeling.Na.

• Brand Name: MITRACLIP SYSTEM STEERABLE GUIDE CATHETER
• Type of Device: VALVE REPAIR
• Manufacturer (Section D): ABBOTT VASCULAR; 26531 ynez rd.; temecula CA 92591 4628
• MDR Report Key: 11037790
• MDR Text Key: 225803172
• Report Number: 2024168-2020-10692
• Device Sequence Number: 1
• Product Code: DRA
• Combination Product (y/n): N
• PMA/PMN Number: K161985
• 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: 03/02/2021

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: 07/28/2021
• Device Catalogue Number: SGC0302
• Device Lot Number: 00726U324
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/04/2021
• Initial Date Manufacturer Received: 11/25/2020
• Initial Date FDA Received: 12/18/2020
• Supplement Dates Manufacturer Received: 02/05/2021
• Supplement Dates FDA Received: 03/02/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1