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

Catalog Number UNK SGC03

Device Problem Material Separation (1562)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 11/19/2020

Event Type  malfunction  

Manufacturer Narrative

The device will not be returned for evaluation; the device was reportedly discarded.Investigation is not yet complete.A follow-up report will be submitted with all additional relevant information.

Event Description

This is being filed to report the distal end of the dilator coming off.It was reported that this was a mitraclip procedure to treat mitral regurgitation (mr).During insertion of the steerable guide catheter (sgc), when advancing the guide wire, the distal end of the dilator came off completely.The distal end was able to be screwed onto the dilator without further issue and the procedure continued.There was no clinically significant delay in the procedure and no adverse patient effects.No additional information was provided.

Manufacturer Narrative

The device was not returned.The lot history record (lhr) review and a similar complaint review were not performed because no device/lot information was provided.All available information was investigated and the reported dilator rotating hemostasis valve detachment appears to be related to a product quality issue.The issue is being addressed per the internal operation procedure.Abbott vascular (av) will continue to trend the performance of these devices.Na.

Manufacturer Narrative

H6: type of investigation codes 4109 and 3331 removed.H6: investigation conclusion code 4315 removed.H6: investigation code 4307 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: 11015749
• MDR Text Key: 222047330
• Report Number: 2024168-2020-10554
• 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,Followup
• Report Date: 06/01/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/16/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: UNK SGC03
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 05/27/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1