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

Catalog Number SGC0301

Device Problem Leak/Splash (1354)

Patient Problem No Patient Involvement (2645)

Event Date 07/26/2019

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).The customer reported the device was discarded.

Event Description

This is filed to report the steerable guide catheter that would not hold the fluid in the hemostatic valve.It was reported that this was a mitraclip procedure to treat grade 4 degenerative mitral regurgitation (mr).Prior to use in the patient, the steerable guide catheter would not hold the fluid column in the hemostatic valve.This sgc was not used in the patient.Another sgc was used to complete the procedure without incident.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.Additionally, a review of the complaint history identified no lot specific quality issue from this lot.All available information was investigated and a definitive cause for the reported leak (loss of fluid column during preparation) could not be determined.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: 8888261
• MDR Text Key: 154140223
• Report Number: 2024168-2019-10799
• 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: 09/10/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/13/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 05/29/2020
• Device Catalogue Number: SGC0301
• Device Lot Number: 90529U321
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 08/22/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1