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

Catalog Number SGC0301

Device Problems Leak/Splash (1354); Difficult to Advance (2920)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 07/03/2019

Event Type  malfunction  

Manufacturer Narrative

The customer reported the device was discarded.Investigation is not yet complete.A follow-up report will be submitted with all additional relevant information.(b)(4).

Event Description

This is filed to report a leak.It was reported that this was a mitraclip procedure to treat degenerative mitral regurgitation (mr) with a grade of 4.Prior to the procedure it was reported that an inferior vena cava (ivc) filter had been previously implanted.While advancing the steerable guide catheter (sgc), difficulty was experienced crossing the ivc filter.The sgc was removed and a balloon was used in an attempt to create room for the sgc to pass through.The sgc was re-inserted but was still unable to cross the ivc filter.The sgc was removed and attempted to be re-flushed; however, a loss of fluid column was observed.The sgc was replaced and two clips were implanted, reducing mr to a grade of 1.There were no adverse patient effects and no clinically significant delay in the procedure.No additional information was provided.

Manufacturer Narrative

Exemption number e2019001-permits numbering sequence to begin with 10000, to avoid duplication of report numbers due to process transition.There may be gaps in numbering for reports submitted during the transition period.The device was not returned for 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 incidents reported for leaks and difficult to advance from this lot.All available information was investigated and the reported difficult to advance the steerable guide catheter (sgc) appears to be due to procedural circumstances; however, a definitive cause for the reported leak (loss of fluid column) could not be determined in this incident.There is no indication of a product quality issue with respect to manufacture, design or labeling.

• Brand Name: STEERABLE GUIDE CATHETER
• Type of Device: VALVE REPAIR
• Manufacturer (Section D): ABBOTT VASCULAR; 26531 ynez rd.; temecula CA 92591 4628
• MDR Report Key: 8822276
• MDR Text Key: 152069223
• Report Number: 2024168-2019-10296
• 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: 08/28/2019

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: 03/25/2020
• Device Catalogue Number: SGC0301
• Device Lot Number: 90326U154
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 07/03/2019
• Initial Date FDA Received: 07/24/2019
• Supplement Dates Manufacturer Received: 08/15/2019
• Supplement Dates FDA Received: 08/28/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1