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

Catalog Number SGC0301

Device Problems Break (1069); Positioning Failure (1158); Noise, Audible (3273)

Patient Problem No Patient Involvement (2645)

Event Date 07/19/2019

Event Type  malfunction  

Manufacturer Narrative

(b)(4).The device was discarded and will not return for analysis.Investigation is not yet complete.A follow-up report will be submitted with all additional, relevant information.

Event Description

This report is filed due to a suspected steerable guide catheter cable break.It was reported that during steerable guide catheter (sgc) preparation, the +/- knob was tested without any unusual resistance noted, when a pop was heard and the catheter was no longer deflecting upon +/- application.A cable break was suspected.The device was discarded and there was no patient involvement.No additional information was provided regarding this device issue.

Manufacturer Narrative

The device was not returned for analysis.A review of the lot history record identified no manufacturing nonconformities issued to the reported lot that would have contributed to this event.Additionally, a review of the complaint history identified no other similar incidents reported from this lot.All available information was investigated, and the investigation was unable to determine a conclusive cause for the reported sgc cable break that resulted in noise and positioning failure.There is no indication of a product quality issue with respect to manufacture, design, or labeling.Exemption number e2019001.

• 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: 8880939
• MDR Text Key: 153991795
• Report Number: 2024168-2019-10723
• 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: 09/04/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/09/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 05/16/2020
• Device Catalogue Number: SGC0301
• Device Lot Number: 90517U124
• 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