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

Catalog Number SGC0302

Device Problems Deformation Due to Compressive Stress (2889); Material Split, Cut or Torn (4008)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 06/17/2020

Event Type  malfunction  

Manufacturer Narrative

The returned device analysis observed a tear on the silicone valve and kink on steerable guide catheter (sgc) tip.A review of the lot history record revealed no manufacturing issued to the reported lot that would have contributed to the reported issue.Additionally, a review of the complaint history identified no similar incidents reported from this lot.All available information was investigated, the reported tear on silicone valve and kink on sgc tip appear to be due to the user technique.There is no indication of a product issue with respect to manufacture, design or labeling.The additional mitraclip delivery system device is filed under a separate medwatch report number.

Event Description

This is being filed to report the damage to steerable guide catheter hemostasis valve.It was reported that this was a mitraclip procedure to treat degenerative mitral regurgitation (mr) with a grade of 3-4.The clip delivery system (cds) was inserted into the patient however it was not possible to steer down to the valve with the m knob.Several attempts were made however were unsuccessful therefore the cds was removed.The device was tested outside the anatomy and worked as intended therefore the cds was re-inserted however again failed to steer down to the valve.The cds was removed and the procedure aborted with the mr remaining at 3-4.There was no clinically significant delay in the procedure and no adverse patient effects.Return device analysis noted the clip cover was torn and the steerable guide catheter (sgc) soft tip was deformed and the silicone valve inside the hemostasis valve was torn.No additional information was provided.

• Brand Name: MITRACLIP SYSTEM STEERABLE GUIDE CATHETER
• Type of Device: VALVE REPAIR
• Manufacturer (Section D): ABBOTT VASCULAR; 26531 ynez rd.; temecula CA 92591 4628
• Manufacturer (Section G): ABBOTT VASCULAR, REG # 3005070406; 3885 bohannon drive; menlo park CA 94025
• Manufacturer Contact: lindsey bell ; 26531 ynez rd.; temecula, CA 92591-4628 ; 9519143996
• MDR Report Key: 10368029
• MDR Text Key: 201872033
• Report Number: 2024168-2020-06521
• Device Sequence Number: 1
• Product Code: DRA
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: K161985
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 08/05/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/05/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 02/18/2021
• Device Catalogue Number: SGC0302
• Device Lot Number: 00218U217
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/16/2020
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 07/16/2020
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/19/2020
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Age: 77 YR