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

Model Number SGC0301

Device Problems Failure to Advance (2524); Deformation Due to Compressive Stress (2889)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 08/06/2020

Event Type  malfunction  

Manufacturer Narrative

The device will not be returned for evaluation, the device was reportedly discarded.Investigation is not yet complete.A follow-up report will be submitted with all additional relevant information.

Event Description

This is filed to report steerable guide catheter soft tip damage.It was reported that this was a mitraclip procedure to treat functional mitral regurgitation (mr) with an mr grade of 4+.The steerable guide catheter (sgc), failed to cross the septum.Several techniques to advance the sgc were unsuccessful, the sgc shaft would bend due to resistance of the septum to crossing.The sgc was removed and the soft tip was noted to be damaged/ mangled; therefore the sgc was no longer used.The septum was ballooned, and a new sgc was attempted, but also could not cross the septum; therefore, the procedure was aborted.No clips were implanted, and mr remained at 4+.There were no adverse patient effects and no clinically significant delay during the procedure.No additional information was provided.

Manufacturer Narrative

The device was not returned for 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.Based on the information provided a conclusive cause for the reported failure to cross septum cannot be determined.The reported damaged soft tip and bent steerable guide catheter (sgc) shaft are the result of the failure to cross as the sgc was damaged while attempting to cross the septum.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: 10463373
• MDR Text Key: 204935535
• Report Number: 2024168-2020-07194
• Device Sequence Number: 1
• Product Code: DRA
• UDI-Device Identifier: 08717648216824
• UDI-Public: 08717648216824
• 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,health
• Type of Report: Initial,Followup
• Report Date: 10/05/2020

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: 03/26/2021
• Device Model Number: SGC0301
• Device Catalogue Number: SGC0301
• Device Lot Number: 00325U127
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 08/06/2020
• Initial Date FDA Received: 08/27/2020
• Supplement Dates Manufacturer Received: 09/17/2020
• Supplement Dates FDA Received: 10/05/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 57 YR
• Patient Weight: 71