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 04/22/2020

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.The additional device listed is filed under a separate medwatch report.

Event Description

This is filed to capture the device unable to straighten.It was reported that this was a mitraclip procedure to treat functional mitral regurgitation (mr) with a grade of 4.During preparation of the clip delivery system (cds) (91008u183), the grippers did not lower to 120 degrees.Troubleshooting was performed, but the issue was unable to be resolved.The cds was not used and was replaced.Two clips were successfully implanted reducing mr to a grade of 2; however, when the steerable guide catheter (sgc) (91101u123) was removed from the femoral vein, the +/- knob was not functioning.It was noted that the sgc function as intended during the procedure.However, when the sgc was removed, it was noticed that the sgc was unable to be straightened.A cable break was also suspected.The sgc was then tested outside the anatomy and the - knob continued to not work.No additional devices were used in the procedure.There were no adverse patient effects and no clinically significant delay in the procedure.No additional information was provided.

Event Description

Subsequent to the initially filed report, the following information was received: the minus knob of the steerable guide catheter could only be turned up to about 270 degrees during preparation and the procedure.

Manufacturer Narrative

All available information was investigated and the reported cable break and unable to straighten the steerable guide catheter (sgc) were confirmed via returned device analysis.The reported unable to curve and mechanical jam of the knob was not confirmed.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 similar complaints reported from this lot.The investigation determined the reported inability to straighten the sgc appears to be related to ¿-¿ cable break.However, a conclusive cause for the cable break, knob jam and inability to curve the sgc cannot be determined.There is no indication of a product issue with respect to manufacture, design or labeling.H6: code 2983 added.

• 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: 10039857
• MDR Text Key: 191988444
• Report Number: 2024168-2020-04207
• 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,distri
• Type of Report: Initial,Followup
• Report Date: 06/22/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/08/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 10/31/2020
• Device Catalogue Number: SGC0302
• Device Lot Number: 91101U123
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/08/2020
• Date Manufacturer Received: 06/09/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 80 YR
• Patient Weight: 57