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

Catalog Number SGC0302

Device Problems Break (1069); Deformation Due to Compressive Stress (2889); Difficult to Advance (2920)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 05/12/2021

Event Type  malfunction  

Manufacturer Narrative

The device was returned.Investigation is not yet complete.A follow-up report will be submitted with all additional relevant information.

Event Description

This is filed to report a break it was reported this was a mitraclip procedure to treat functional mitral regurgitation (mr) with a grade of 4.The steerable guide catheter (sgc) was inserted attempted to be advanced up the femoral vein.However, due to a kink in the vein, resistance was felt during advanced.To advance the sgc, the physician applied more pressure, but this caused the tip of the guide to bend more than 90 degrees resulting in a break of the shaft.The sgc was removed and replaced.It was noted that no damage was caused vein and no resistance was encountered when removing the guide.Due to the kink, a new guidewire was inserted and a new sgc was able to advance into the left atrium (la).One clip was implanted, reducing mr to a grade of 2.There were no adverse patient effects and no clinically significant delay in the procedure.No additional information was provided.

Manufacturer Narrative

All available information was investigated, and the returned steerable guide catheter (sgc) could not replicate the reported difficult to advance in the testing environment.The reported shaft break was not confirmed during returned device analysis as no issue was noted.However, deformation due to compressive stress was confirmed during returned device analysis.A review of the lot history record revealed no manufacturing nonconformities issued to the reported lot.Additionally, a review of the complaint history identified no other complaints 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 difficult to advance was due to challenging patient anatomy.The reported deformation due to compressive stress and the observed material deformation as noted during return device analysis are cascading events of the reported difficulty advancing the sgc/user applying excessive pressure.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: 11921704
• MDR Text Key: 253776073
• Report Number: 2024168-2021-04581
• 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: 07/08/2021

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: 12/10/2021
• Device Catalogue Number: SGC0302
• Device Lot Number: 01210U141
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/01/2021
• Initial Date Manufacturer Received: 05/12/2021
• Initial Date FDA Received: 06/02/2021
• Supplement Dates Manufacturer Received: 06/22/2021
• Supplement Dates FDA Received: 07/08/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1