MAUDE Adverse Event Report: ABBOTT VASCULAR HI-TORQUE BALANCE MIDDLEWEIGHT GUIDE WIRES

Catalog Number	1001782J-HC
Medical Device Problem Codes	Break (1069); Difficult to Remove (1528); Stretched (1601)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/14/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Manufacturer's investigation is still pending at this time.Results and conclusions will be provided in the final report.
Event or Problem Description
It was reported that during the procedure to treat a lesion in an unspecified artery.The hi-torque (ht) balance middleweight (bmw) guide wire was more difficult than normal upon removal.When the guide wire was removed, the tip was stripped and damaged, noting that the coils detached from the tip but remains in one piece.There was no adverse patient effect and there was no clinically significant delay in the procedure.No additional information was provided.
Event or Problem Description
It was reported that during the procedure to treat a lesion in an unspecified artery.The hi-torque (ht) balance middleweight (bmw) guide wire was more difficult than normal upon removal.When the guide wire was removed, the tip was stripped and damaged noting that the coils detached from the tip but remains in one piece.There was no adverse patient effect and there was no clinically significant delay in the procedure.Subsequent to the initially filed report, the following information was provided: there was no resistance during removal, however, it was more difficult than normal.Returned device analysis identified that the entire shaping ribbon and nitinol tip solder tip were not returned.The account confirmed the separation; however, unsure when the separation occurred.Fluoroscopy was performed to confirm nothing remained in the anatomy.No additional information was provided.
Additional Manufacturer Narrative
A visual inspection was performed on the returned device.The reported material separation and stretched coils were confirmed.The reported difficult to remove could not be tested due to the device condition.A review of the corrective and preventive actions (capa) database was performed and revealed no related complaint assessment capas.The electronic lot history record (elhr) review identified no associated manufacturing nonconformities issued to the reported lot.Additionally, a query of the complaint handling database for the reported lot revealed no indication of a lot specific issue.The investigation was unable to determine a conclusive cause for the reported difficulties.In this case, the account reported difficulty when removing the guide wire from the anatomy.Factors that may contribute to difficulty removing the guide wire from the anatomy include, but are not limited to, outer diameter of the guide wire, device support, buildup of procedural contaminants, user technique, and/or damage to the guide wire.Based on the information provided and the returned device analysis, it is unknown what may have caused the reported difficulty during removal.Additionally, the returned device analysis confirmed stretched coils and a solder/ shaping ribbon separation.This type of damage is consistent with manipulation against resistance.It is possible that when the guide wire encountered difficulty during removal, manipulation of the wire contributed to the reported stretched coils and material separation.There is no indication of a product quality issue with respect to manufacture, design, or labeling.H6: medical device problem code - 1069 removed and replaced with 1562.

• Brand Name: HI-TORQUE BALANCE MIDDLEWEIGHT GUIDE WIRES
• 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: 18831927
• Report Number: 2024168-2024-02703
• Device Sequence Number: 3047366
• Product Code: DQX
• UDI-Device Identifier: 08717648026010
• UDI-Public: (01)08717648026010(17)250131(10)3021571
• Combination Product (Y/N): N
• Initial Reporter Country: SP
• PMA/510(K) Number: K021228
• 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
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 04/22/2024

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: 01/31/2025
• Device Catalogue Number: 1001782J-HC
• Device Lot Number: 3021571
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 02/14/2024
• Supplement Date Received by Manufacturer: 04/08/2024
• Initial Report FDA Received Date: 03/04/2024
• Supplement Report FDA Received Date: 04/22/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/15/2023
• 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
• Patient Sex: Unknown