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

Model Number SGC0301

Device Problems Break (1069); Unstable (1667)

Patient Problem No Patient Involvement (2645)

Event Date 05/05/2020

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 broken hemostatic valve.It was reported that during preparation, the hemostatic valve of the dilation would not hit a hard stop and continued to turn.The dilator and steerable guide catheter (sgc) were not used and were replaced.There was no clinically significant delay in the procedure.No additional information was provided.

Event Description

Subsequent to the initially filed report, the following information was received: the issue was with the hemostatic valve cap.No additional information was provided.

Manufacturer Narrative

All available information was investigated, and the reported unstable rotating hemostatic valve (rhv) cap was not confirmed via returned device analysis.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 similar complaints reported from this lot.All available information was investigated and a cause for the reported unstable rhv cap could not be determined.There is no indication of a product issue with respect to manufacture, design or labeling.H6: device code 1069 removed and code 1667 added.

• 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: 10075141
• MDR Text Key: 191585500
• Report Number: 2024168-2020-04418
• 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: 06/25/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/20/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 11/11/2020
• Device Model Number: SGC0301
• Device Catalogue Number: SGC0301
• Device Lot Number: 91112U213
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/29/2020
• Date Manufacturer Received: 06/19/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1