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.

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 similar complaints reported from this lot.Based on the information reviewed, a conclusive cause for the reported unstable could not be determined.There is no indication of a product 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: 9131054
• MDR Text Key: 160499657
• Report Number: 2024168-2019-12176
• 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: 10/22/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 05/31/2020
• Device Catalogue Number: SGC0301
• Device Lot Number: 90531U109
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 09/09/2019
• Initial Date FDA Received: 09/27/2019
• Supplement Dates Manufacturer Received: 10/16/2019
• Supplement Dates FDA Received: 10/22/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1