MAUDE Adverse Event Report: AV-TEMECULA-CT GUIDE WIRE ACC.KIT W/COPILOT; HEMOSTATIC VALVE

Catalog Number 1003330

Device Problems Break (1069); Device Operates Differently Than Expected (2913)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 08/06/2017

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Evaluation summary: visual inspection was performed on the returned device.The reported difficulty tightening the clamp seal was confirmed due to the broken cap.It may be possible that during tightening of the clamp seal, the cap was over-rotated causing the threaded portion of the cap to break; however, this could not be 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 revealed no other incidents.The investigation was unable to determine a cause for the broken cap.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 during preparation of the device, the copilot clamp seal could not be tightened when connecting the copilot to the guiding catheter.The copilot was not used.A new copilot was prepped and used successfully for the case.There was no clinically significant delay in the procedure due to the device issue.No additional information was provided.The returned device analysis noted that the threaded cap was broken in 2 pieces.

• Brand Name: GUIDE WIRE ACC.KIT W/COPILOT
• Type of Device: HEMOSTATIC VALVE
• 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: 6959901
• MDR Text Key: 90633502
• Report Number: 2024168-2017-08315
• Device Sequence Number: 1
• Product Code: DTL
• UDI-Device Identifier: 08717648013980
• UDI-Public: 08717648013980
• Combination Product (y/n): N
• Reporter Country Code: CH
• PMA/PMN Number: K991102
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,distri
• Reporter Occupation: Health Professional
• Remedial Action: Other
• Type of Report: Initial
• Report Date: 10/18/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/18/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 08/31/2018
• Device Catalogue Number: 1003330
• Device Lot Number: 51011107
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/28/2017
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/12/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/01/2016
• 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