MAUDE Adverse Event Report: AV-TEMECULA-CT ROTATING HEMOSTATIC VALVE; ACCESSORIES

Catalog Number 23245

Device Problems Leak/Splash (1354); Device Operates Differently Than Expected (2913)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 03/19/2017

Event Type  malfunction  

Manufacturer Narrative

(b)(4).During processing of this complaint, attempts were made to obtain complete event, patient and device information.The additional rotating hemostatic valve referenced is being filed under a separate medwatch report#.Evaluation summary: the device was returned for analysis.Visual, dimensional, and functional inspections were performed on the returned device.The leak and device operates differently then expected were not confirmed.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 of the reported lot did not indicate a lot specific quality issue.The investigation was unable to determine a conclusive cause for the reported difficulties.There is no indication of a product quality issue with respect to the design, manufacture, or labeling of the device.

Event Description

It was reported that the procedure was to treat a lesion in the left anterior descending artery and diagonal artery.It was reported that two rotating hemostatic valves (rhv) were attempted to be used in the case; however, when the valves were turned they did not tighten on the guide wire; which, caused leaking.A new rhv was used to complete the case.No adverse patient effects or clinically significant delay in the procedure were reported.No additional information was provided.

• Brand Name: ROTATING HEMOSTATIC VALVE
• Type of Device: ACCESSORIES
• Manufacturer (Section D): AV-TEMECULA-CT; abbott vascular; 26531 ynez road; temecula CA 92591 4628
• Manufacturer (Section G): ABBOTT VASCULAR, TEMECULA, CA USA REG# 2024168; abbott vascular; 26531 ynez road; temecula CA 92591 4628
• Manufacturer Contact: connie speck ; abbott vascular; 26531 ynez road; temecula, CA 92591-4628 ; 9519143996
• MDR Report Key: 6477262
• MDR Text Key: 72502602
• Report Number: 2024168-2017-02982
• Device Sequence Number: 1
• Product Code: DYB
• UDI-Device Identifier: 08717648013386
• UDI-Public: (01)08717648013386(17)181231(10)60038283
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K934624
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Health Professional
• Remedial Action: Other
• Type of Report: Initial
• Report Date: 04/10/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/10/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 12/31/2018
• Device Catalogue Number: 23245
• Device Lot Number: 60038283
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/24/2017
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/20/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/01/2017
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Age: 57 YR
• Patient Weight: 92