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 10/17/2019

Event Type  malfunction  

Manufacturer Narrative

Exemption number e2019001. Product performance engineering reviewed the incident information provided to abbott vascular, manufacturing records, complaint history for the reported lot and performed analysis of the returned device. Based on the returned device analysis the reported leak could not be confirmed. The discrepancy between what was reported (inability to de-air) and what was observed (successful de-airing with no leakage) may have been due to the user technique while de-airing/aspiration of the sgc during preparation versus the returned product analysis. In conclusion a definitive cause for the reported leak could not be determined in this incident. 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 from this lot. There is no indication of a product issue with respect to manufacture, design or labeling.

Event Description

This is being filed to report a leak. It was reported that during preparation of a steerable guide catheter (sgc), it was not possible to de-air the sgc indicating a possible leak. The procedure was successfully completed with a new sgc. There was no patient involvement and no clinically significant delay in the procedure. No additional information was provided.

• Brand Name: STEERABLE GUIDE CATHETER
• Type of Device: VALVE REPAIR
• Manufacturer (Section D): ABBOTT VASCULAR; 26531 ynez rd.; temecula CA 92591 4628
• Manufacturer (Section G): ABBOTT VASCULAR, REG # 3005070406; 3885 bohannon drive; menlo park CA 94025
• Manufacturer Contact: lindsey bell ; 26531 ynez rd.; temecula, CA 92591-4628 ; 9519143996
• MDR Report Key: 9280527
• MDR Text Key: 175226971
• Report Number: 2024168-2019-13223
• Device Sequence Number: 1
• Product Code: DRA
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K161985
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health

Reporter Occupation

• Type of Report: Initial
• Report Date: 11/05/2019

1 Device was Involved in the Event

0 Patients were Involved in the Event:

• Date FDA Received: 11/05/2019
• Is this a Product Problem Report?: Yes

Device Operator

• Device Expiration Date: 07/21/2020
• Device Catalogue Number: SGC0301
• Device Lot Number: 90722U157
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/28/2019
• Is the Reporter a Health Professional?: Yes

Was the Report Sent to FDA?

• Event Location: No Information
• Date Manufacturer Received: 10/17/2019
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/22/2019
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial