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

Catalog Number SGC0302

Device Problems Positioning Failure (1158); Failure to Advance (2524); Deformation Due to Compressive Stress (2889)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 01/27/2020

Event Type  malfunction  

Manufacturer Narrative

The customer reported the device was discarded.Investigation is not yet complete.A follow-up report will be submitted with all additional relevant information.

Event Description

This is filed to report the inability to straighten the sgc tip.It was reported that this was a mitraclip procedure to treat a functional mitral regurgitation (mr) with grade of 3-4.The steerable guide catheter (sgc) tip got damaged due to the abnormal tortuosity of the femoral vein.The sgc tip was so bent that it could not be straightened anymore after the damage.The physician decided to discard the sgc and a new a sgc was used to complete the procedure.One clip was implanted, reducing mr to 1-2.There was no adverse patient effect.No additional information was provided.

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.Additionally, a review of the complaint history identified no other incidents reported from this lot.Based on information reviewed, it appears that bend was a result of the patient morphology/pathology.The positioning failure and failure to advance were cascading effects of the bend.There is no indication of a product quality issue with respect to manufacture, design or labeling.

• Brand Name: STEERABLE GUIDE CATHETER
• Type of Device: VALVE REPAIR
• Manufacturer (Section D): ABBOTT VASCULAR; 26531 ynez rd.; temecula CA 92591 4628
• MDR Report Key: 9717414
• MDR Text Key: 179719226
• Report Number: 2024168-2020-01534
• 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,foreig
• Type of Report: Initial,Followup
• Report Date: 03/03/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/17/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 06/09/2020
• Device Catalogue Number: SGC0302
• Device Lot Number: 90608U112
• Date Manufacturer Received: 02/17/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1