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

Catalog Number SGC0302

Device Problems Break (1069); Unintended Movement (3026)

Patient Problem No Patient Involvement (2645)

Event Date 12/12/2019

Event Type  malfunction  

Manufacturer Narrative

The device was 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 that the return device analysis found the steerable guide catheter cable broken.It was reported that this was a mitraclip procedure to treat mitral regurgitation.During preparation of the steerable guide catheter (sgc), functional testing failed as the knob would slip.When the + knob was turned, the guide turned back jerkily and the +/- knob did not move as usual.There was no patient involvement and no clinically significant delay in the procedure.Based on the return device analysis, a sgc cable break was noted.No additional information was provided.

Manufacturer Narrative

The device was investigated, and the returned device analysis confirmed the reported issue due to the observed broken ¿+¿ cable.A review of the lot history record identified no exception issued to the reported lot.Additionally, a review of the complaint history identified no similar complaints reported from this lot.All available information was investigated and a definitive cause for the observed cable break could not be determined in this complaint; however, the reported unintended movement was due to the cable break.There is no indication of a product quality issue with respect to manufacture, design, or labeling.

• Brand Name: STEERABLE GUIDE CATHETER
• Type of Device: VALVE REPAIR
• Manufacturer (Section D): ABBOTT VASCULAR; 26531 ynez rd.; temecula CA 92591 4628
• MDR Report Key: 9642726
• MDR Text Key: 177178694
• Report Number: 2024168-2020-00971
• 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: 02/21/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/29/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 07/02/2020
• Device Catalogue Number: SGC0302
• Device Lot Number: 90703U101
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/03/2020
• Date Manufacturer Received: 02/10/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1