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

Catalog Number SGC0302

Device Problems Positioning Failure (1158); Unintended Movement (3026)

Patient Problem No Patient Involvement (2645)

Event Date 10/05/2020

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 unable to straightened tip.It was reported after preparing the steerable guide catheter (sgc), the- +/- knob was applied before insertion.However, the +/- knob rotated more than 360 degrees, and the tip could not be straightened.The procedure was successfully completed with a new sgc.There was no patient involvement, and no reported clinically significant delay in the procedure.No additional information was provided.

Manufacturer Narrative

All available information was investigated and the reported knob issue and positioning failure of unable to straighten the steerable guide catheter (sgc) tip could not be confirmed via returned device analysis.A review of the lot history record revealed no manufacturing nonconformities issued to the reported lot that would have contributed to this event.Additionally, a review of the complaint history identified no similar complaints reported from this lot.The investigation was unable to determine a cause for the reported knob issue and positioning failure of unable to straighten the sgc tip.There is no indication of a product issue with respect to manufacture, design, or labeling.

• 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: 10734323
• MDR Text Key: 213045037
• Report Number: 2024168-2020-08898
• 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: 01/12/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/26/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 03/11/2021
• Device Catalogue Number: SGC0302
• Device Lot Number: 00308U105
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/20/2020
• Date Manufacturer Received: 01/06/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1