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

Model Number SGC0301

Device Problem Deformation Due to Compressive Stress (2889)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 04/20/2020

Event Type  malfunction  

Manufacturer Narrative

The device was returned.The steerable guide catheter (sgc) soft tip was noted to be bent.All available information was investigated, and the observed sgc soft tip damage appears to be due to user technique.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.There is no indication of a product quality issue with respect to manufacture, design or labeling.

Event Description

This is filed to report damaged soft tip.It was reported that this was a mitraclip procedure to treat mixed mitral regurgitation (mr) with a grade of 4.The first ntr clip was successfully deployed, and the clip delivery system (cds) was removed from the steerable guide catheter (sgc).The sgc had a quarter turn of the plus knob left at this time.Then a second ntr cds was advanced into the sgc fine.It was noted that when the clip came out of the guide, the clip was at an angle.The cds continued to be advanced to the mitral valve, and then the clip was opened; however, the clip had prematurely deployed.The clip remained attached to the lock and gripper lines the clip; and therefore, the clip was retracted to the sgc.Both the cds with the clip and sgc were removed as single unit.The procedure continued with a new cds and sgc.Two clips were implanted, reducing mr to 2-3.There were no adverse patient effects and no clinically significant delay in the procedure.Subsequent to the initially filed report, the returned device analysis revealed the steerable guide catheter (sgc) was received with a damaged soft tip.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: 10067362
• MDR Text Key: 191999604
• Report Number: 2024168-2020-04360
• Device Sequence Number: 1
• Product Code: DRA
• UDI-Device Identifier: 08717648216824
• UDI-Public: 08717648216824
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K161985
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 05/18/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/18/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 09/27/2020
• Device Model Number: SGC0301
• Device Catalogue Number: SGC0301
• Device Lot Number: 90927U211
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/06/2020
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 05/06/2020
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/28/2019
• 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: 82 YR
• Patient Weight: 87