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

Catalog Number SGC0302

Device Problem Leak/Splash (1354)

Patient Problem No Patient Involvement (2645)

Event Date 05/29/2020

Event Type  malfunction  

Manufacturer Narrative

The device was returned.Investigation is not yet complete.A follow up report will be submitted with all additional relevant information.

Event Description

This is filed to report a leak.It was reported that during preparation of the steerable guide catheter (sgc), the tip was submerged in heparinized saline, but failed to the 30 second check as air was sucked into the hemostatic valve during this time.The sgc was not used and was replaced.There was no clinically significant delay in the procedure.No additional information was provided.

Manufacturer Narrative

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 other incidents reported from this lot.All available information was investigated and a definitive cause for the reported leak could not be determined.The returned device analysis was unable to confirm a leak.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: 10184333
• MDR Text Key: 196101516
• Report Number: 2024168-2020-05242
• 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: 07/24/2020

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: 03/10/2021
• Device Catalogue Number: SGC0302
• Device Lot Number: 00310U108
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/18/2020
• Initial Date Manufacturer Received: 06/02/2020
• Initial Date FDA Received: 06/23/2020
• Supplement Dates Manufacturer Received: 06/29/2020
• Supplement Dates FDA Received: 07/24/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1