MAUDE Adverse Event Report: AV-TEMECULA-CT HI-TORQUE BALANCE MIDDLEWEIGHT UNIVERSAL II GUIDE WIRE

Catalog Number	1009665
Medical Device Problem Code	Unsealed Device Packaging (1444)
Health Effect - Clinical Code	No Patient Involvement (2645)
Date of Event	03/11/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).Internal file number - (b)(4): during processing of this complaint, attempts were made to obtain complete event, patient and device information.The additional eight hi-torque bmw universal ii devices referenced are being filed under separate medwatch reports.Evaluation summary: the device was returned for analysis.The unsealed device packaging was unable to be confirmed however there were noted bubbles sporadically throughout both the manufacture seal and the vender seal.A review of the lot history record identified one manufacturing nonconformity issued to the reported lot related to this event.The investigation determined the reported difficulties appears to be related to a potential product quality issue.The issue is being addressed per internal operating procedures.Abbott vascular will continue to trend the performance of these devices.
Event or Problem Description
It was reported that during an incoming consignment inspection of nine high-torque balance middle weight universal ii guide wires, there was what appeared to be air bubbles inside the sterile packaging around the seals.While the seals appeared intact and there was no reported problem with sterility of the guide wires, this could not be confirmed.The guide wires were not used and there was no patient involvement.No additional information was provided.

• Brand Name: HI-TORQUE BALANCE MIDDLEWEIGHT UNIVERSAL II GUIDE WIRE
• Common Device Name: GUIDE WIRE
• Manufacturer (Section D): AV-TEMECULA-CT; abbott vascular; 26531 ynez road; temecula CA 92591 4628
• MDR Report Key: 8478944
• Report Number: 2024168-2019-02580
• Device Sequence Number: 1062795
• Product Code: DQX
• UDI-Device Identifier: 08717648118722
• UDI-Public: 08717648118722
• Combination Product (Y/N): N
• Initial Reporter State: IL
• Initial Reporter Country: US
• PMA/510(K) Number: K072460
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Other Health Care Professional
• Remedial Action: Other
• Type of Report: Initial
• Report Date (Section B): 04/03/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 01/31/2021
• Device Catalogue Number: 1009665
• Device Lot Number: 9022571
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/21/2019
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/14/2019
• Initial Report FDA Received Date: 04/03/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1