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

Catalog Number SGC0302

Device Problems Failure to Advance (2524); Deformation Due to Compressive Stress (2889)

Patient Problem Insufficient Information (4580)

Event Date 02/01/2021

Event Type  malfunction  

Manufacturer Narrative

The device was not returned for analysis.A review of the lot history record identified no manufacturing nonconformities issued to the reported lot that would have contributed to the reported event.Additionally, a review of the complaint history identified no other complaints from the lot.All available information was investigated and the reported failure to advance the steerable guide catheter (sgc) resulting in the deformation of the soft tip (deformation due to compressive stress) appears to be related to patient conditions.There is no indication of a product issue with respect to manufacture, design or labeling.

Event Description

This is filed to report the soft tip damage.It was reported this was a mitraclip procedure to treat grade 4 degenerative mitral regurgitation (mr).Due to the complex femoral access, the steerable guide catheter (sgc) failed to cross the septum and the sgc soft tip went flat.The sgc was removed and was replaced.Two clips were implanted, reducing mr to 1.There were no adverse patient effects and no clinically significant delay during the procedure.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: 11346910
• MDR Text Key: 233803424
• Report Number: 2024168-2021-01316
• Device Sequence Number: 1
• Product Code: DRA
• Combination Product (y/n): N
• Reporter Country Code: FR
• 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: 02/18/2021

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: 09/24/2021
• Device Catalogue Number: SGC0302
• Device Lot Number: 00924U125
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 02/01/2021
• Initial Date FDA Received: 02/18/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/24/2020
• 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