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

Model Number SGC0301

Device Problem Leak/Splash (1354)

Patient Problem No Patient Involvement (2645)

Event Date 05/08/2020

Event Type  malfunction  

Manufacturer Narrative

The device is expected to be returned for evaluation.It has not yet been received.A follow up report will be submitted with all additional relevant information.

Event Description

This is filed to report a loss of fluid column during preparation.It was reported that during preparation of the steerable guide catheter (sgc), a loss of fluid column occurred.The physician decided to not use the sgc and replace it.There was no clinically significant delay in the procedure.No additional information was provided.

Manufacturer Narrative

The returned analysis could not confirm the reported leak (loss of fluid column) during testing.A review of the lot history record identified no manufacturing nonconformities issued to the reported lot that would have influenced the reported issues.Additionally, a review of the complaint history did not identify any similar incidents.The discrepancy between what was reported (loss of fluid column) during preparation and what was observed (no issues) was likely due to procedural condition/user technique and resulted in the reported user experience, however, this cannot be confirmed.Based on the information reviewed, the cause for the steerable guide catheter (sgc) leak during prep could not be determined.There is no indication of a product issue with respect to manufacture, design or labeling.Na.

• 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: 10075271
• MDR Text Key: 191586533
• Report Number: 2024168-2020-04425
• 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: 09/10/2020

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: 02/12/2021
• Device Model Number: SGC0301
• Device Catalogue Number: SGC0301
• Device Lot Number: 00213U124
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/25/2020
• Initial Date Manufacturer Received: 05/08/2020
• Initial Date FDA Received: 05/20/2020
• Supplement Dates Manufacturer Received: 08/28/2020
• Supplement Dates FDA Received: 09/10/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1