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

Catalog Number UNK SGC

Device Problems Leak/Splash (1354); Failure to Advance (2524)

Patient Problem Mitral Valve Insufficiency/ Regurgitation (4451)

Event Date 09/05/2023

Event Type  malfunction  

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 available information, the reported failure to advance (septum) was due to challenging patient anatomy (thick septum).Without the device to analyze, the cause of the reported leak / splash (loss of fluid column during prep) could not be determined.There is no indication of a product quality issue with respect to manufacture, design, or labeling.Na.

Event Description

This is filed to report a leak.It was reported this was a mitraclip procedure to treat functional mitral regurgitation (mr) with a grade of 4 and thick septum.The steerable guide catheter (sgc) was inserted, but was unable to cross the septum.It was noted the sgc was removed and advanced multiple times in an attempt to cross the septum.However, after removing the sgc a couple times, while re-prepping the device, a loss of fluid column occurred.Therefore, the physician decided to discontinue the procedure.Mr remained at a grade of 4.There was no clinically significant delay in the procedure and no adverse patient affects.No additional information was provided.

• Brand Name: MITRACLIP® SYSTEM STEERABLE GUIDE CATHETER
• Type of Device: VALVE REPAIR
• Manufacturer (Section D): ABBOTT MEDICAL; 5050 nathan lane n; plymouth MN 55442
• Manufacturer (Section G): ABBOTT VASCULAR, REG # 3005070406; 3885 bohannon drive; menlo park CA 94025
• Manufacturer Contact: karen krouse ; 5050 nathan lane n; plymouth, MN 55442 ; 6517565400
• MDR Report Key: 17821913
• MDR Text Key: 324867570
• Report Number: 2135147-2023-04191
• Device Sequence Number: 1
• Product Code: DRA
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K112239
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 09/26/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/26/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: UNK SGC
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 09/05/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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: 84 YR
• Patient Sex: Female
• Patient Weight: 60 KG