MAUDE Adverse Event Report: ABBOTT VASCULAR HI-TORQUE BALANCE MIDDLEWEIGHT UNIVERSAL II GUIDE WIRE

Catalog Number	1009665
Medical Device Problem Codes	Peeled/Delaminated (1454); Difficult to Advance (2920)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	03/05/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the ht bmw universal ii 300cm guidewire (gw) was attempted to be used in a procedure; however, the tip of the gw was catching during advancement on the introducer needle while the gw was still in the guide catheter.Therefore, the gw was removed from the patient and the teflon coating of the gw was noted to be missing and a transition bump was felt.It is unknown if anything was left in the anatomy.There was no adverse patient effect and no clinically significant delay reported in the procedure.No additional information was provided.
Additional Manufacturer Narrative
Manufacturer's investigation is still pending at this time.Results and conclusions will be provided in the final report.
Additional Manufacturer Narrative
The device was returned for analysis.The reported difficult to advance and the reported peeled / delaminated were unable to be confirmed.The coils were stretched for a length of 2mm.Electronic lot history record (lhr) and corrective and preventive actions (capa) reviews were performed and revealed no indication of a product quality issue.Additionally, a review of the complaint handling database identified no other incidents from this lot.As there was no damage noted to the guide wire during the inspection prior to use, the investigation determined the reported difficulties appear to be related to circumstances of the procedure as it is likely that a coagulation of blood and/or contrast on the guide wire resulted in the reported difficult to advance.Manipulation of the device resulted in the noted stretched coils likely contributing to the reported difficult to advance.The reported peeled teflon coating was not confirmed.Based on the reported information and results of the complaint investigation there is no indication of a product quality issue with respect to the design, manufacture, or labeling of the device.E1 - facility name updated from (b)(6).

• Brand Name: HI-TORQUE BALANCE MIDDLEWEIGHT UNIVERSAL II GUIDE WIRE
• Common Device Name: GUIDE WIRE
• Manufacturer (Section D): ABBOTT VASCULAR; 26531 ynez rd.; temecula CA 92591 4628
• Manufacturer (Section G): ABBOTT VASCULAR, REG # 3005737652; road no.2 km 58.0 cruce dávila; barceloneta PR 00617
• Manufacturer Contact: lindsey bell ; 26531 ynez rd.; temecula, CA 92591-4628 ; 9519143996
• MDR Report Key: 18983812
• Report Number: 2024168-2024-03724
• Device Sequence Number: 2867835
• Product Code: DQX
• UDI-Device Identifier: 08717648118722
• UDI-Public: (01)08717648118722(17)241231(10)3012771
• Combination Product (Y/N): N
• PMA/510(K) Number: K072460
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative,Distributor
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 05/16/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 12/31/2024
• Device Catalogue Number: 1009665
• Device Lot Number: 3012771
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: Not provided
• Supplement Date Received by Manufacturer: 05/01/2024
• Initial Report FDA Received Date: 03/26/2024
• Supplement Report FDA Received Date: 05/16/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/27/2023
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown