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

Model Number SGC0301

Device Problems Difficult to Insert (1316); Failure to Advance (2524); Deformation Due to Compressive Stress (2889); Physical Resistance/Sticking (4012)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 07/01/2020

Event Type  malfunction  

Manufacturer Narrative

The customer reported the device is not returning.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 soft tip damage on the steerable guide catheter.It was reported that this was a mitraclip procedure to treat grade 4 degenerative mitral regurgitation (mr).The steerable guide catheter (sgc) was difficult to insert through the right femoral vein access site and met resistance with the tortuous anatomy as it was advanced to the right atrium.The sgc was unable to cross the septum and the physician decided to remove this sgc and replace it with a new one.Outside the anatomy, the sgc was noted to be misshapen at the tip; the tip was no longer circular.A balloon dilatation catheter (bdc) was advanced to the septum where the septum was dilated with the bdc.A new sgc was inserted without resistance and used to complete the procedure without further incident.One mitraclip was implanted reducing mr to grade 2.There were no adverse patient effects and no clinically significant delay in the procedure.There was no additional information 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 that would have contributed to the reported event.Additionally, a review of the complaint history did not indicate a lot-specific product issue.All available information was investigated and the reported difficult to insert, failure to advance the sgc and resistance with the anatomy (physical resistance/sticking) resulting in the misshapen 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.

• Brand Name: MITRACLIP SYSTEM STEERABLE GUIDE CATHETER
• Type of Device: VALVE REPAIR
• Manufacturer (Section D): ABBOTT VASCULAR; 26531 ynez rd.; temecula CA 92591 4628
• MDR Report Key: 10292425
• MDR Text Key: 199511809
• Report Number: 2024168-2020-05959
• Device Sequence Number: 1
• Product Code: DRA
• UDI-Device Identifier: 08717648216824
• UDI-Public: 08717648216824
• 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,health
• Type of Report: Initial,Followup
• Report Date: 08/11/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/17/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 01/01/2021
• Device Model Number: SGC0301
• Device Catalogue Number: SGC0301
• Device Lot Number: 00102U124
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 07/21/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 69 YR
• Patient Weight: 72