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

Catalog Number SGC0301

Device Problem Unstable (1667)

Patient Problem No Patient Involvement (2645)

Event Date 09/09/2019

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

This report is filed as the rotating hemostatic valve was unable to fully tighten. It was reported that during steerable guide catheter preparation, the rotating hemostatic valve (rhv) on the dilator was unable to fully tighten and would not stay connected. Reportedly, the technician might have over-tightened the rhv, however, this was not observed or confirmed. There was no issue observed with the threading. The device was set aside and not used in a patient. There was no patient involvement. No additional information was provided regarding this issue.

• 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: 9131054
• MDR Text Key: 160499657
• Report Number: 2024168-2019-12176
• 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,Followup
• Report Date: 10/22/2019

1 Device was Involved in the Event

0 Patients were Involved in the Event:

• Date FDA Received: 09/27/2019
• Is this a Product Problem Report?: Yes

Device Operator

• Device Expiration Date: 05/31/2020
• Device Catalogue Number: SGC0301
• Device Lot Number: 90531U109
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes

Was the Report Sent to FDA?

• Event Location: No Information
• Date Manufacturer Received: 10/16/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/01/2019
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial