MAUDE Adverse Event Report: ABBOTT VASCULAR STEERABLE GUIDE CATHETER 03; VALVE REPAIR

Catalog Number SGC0302

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Respiratory Failure (2484); Atrial Perforation (2511)

Event Date 09/17/2020

Event Type  Injury  

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 filed to report atrial perforation and intervention.It was reported that this was a mitraclip procedure to treat mixed mitral regurgitation (mr) with a grade of 4.It was noted that prior to the mitraclip procedure, a balloon aortic valvuloplasty (bav)-like procedure was performed with the tricuspid valve to solve tricuspid valve (tv) stenosis of 25 mm.The steerable guide catheter (sgc) was advanced to the mitral valve, and one clip was deployed.However, after the sgc was removed, a left to right shunt was observed and the patient's oxygen level dropped to about 85.An amplatzer was used with the use of a swan guntz catheter to close the atrial perforation.The hemodynamics of the patient had returned to the original levels.One clip was implanted, reducing mr to 2.There was a reported delay in the procedure.No additional information was provided.

Manufacturer Narrative

The device was not returned for analysis.A review of the lot history record revealed no manufacturing nonconformities issued to the reported lot.The investigation was unable to determine a cause for the reported atrial perforation.The respiratory failure (hemodynamics) appears to be related to the atrial perforation.Atrial perforation and respiratory failure are listed in the instructions for use as known possible complications associated with mitraclip procedures.The reported delayed additional therapy/non-surgical treatment and additional therapy/non-surgical treatment were results of case specific circumstance.There is no indication of a product issue with respect to manufacture, design, or labeling.Na.

• Brand Name: STEERABLE GUIDE CATHETER 03
• Type of Device: VALVE REPAIR
• Manufacturer (Section D): ABBOTT VASCULAR; 26531 ynez rd.; temecula CA 92591 4628
• MDR Report Key: 10656001
• MDR Text Key: 210621738
• Report Number: 2024168-2020-08432
• 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: 11/29/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/09/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 04/15/2021
• Device Catalogue Number: SGC0302
• Device Lot Number: 00413U326
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 11/11/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention