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

Catalog Number	1009666J
Medical Device Problem Codes	Peeled/Delaminated (1454); Difficult to Remove (1528); Difficult to Advance (2920)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/15/2023
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the procedure was to treat a lesion in the circumflex (cx) artery with mild calcification and mild tortuosity.The hi-torque (ht) balance middleweight (bmw) universal ii guide wire was noted to have delaminated catching on the ultrasound guided catheter.The black polymer coating was noted to have peeled.The guide wire and the ultrasound guided catheter were removed as a unit and managing to be removed with abrupt force.Another non-abbott guide wire was used to complete the procedure.There was no adverse patient effect and there was no clinically significant delay 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
Correction: d9 - device available for evaluation updated from ¿yes¿ to ¿no¿.The device was returned for analysis.Electronic lot history record (elhr) and exception reviews were performed and revealed no indication of a product quality issue.Additionally, a query of the complaint handling database for the reported lot revealed there is no indication of a lot level product quality issue.As there was no damage noted to the device 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 interaction with the ultrasound guided catheter was due to the mildly calcified and mildly tortuous anatomy and/or a coagulation of blood/contrast on the guide wire resulted in the reported difficult to advance and the reported difficult to remove.Interaction and/or manipulation of the device(s) resulted in the reported peeled black polymer coating.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.
Additional Manufacturer Narrative
The device was returned for analysis.The reported peeled / delaminated was unable to be confirmed.The reported difficult to advance and the reported difficult to remove were unable to be replicated in a testing environment as they were based on operational circumstances.Electronic lot history record (elhr) and exception reviews were performed and revealed no indication of a product quality issue.Additionally, a query of the complaint handling database for the reported lot revealed there is no indication of a lot level product quality issue.As there was no damage noted to the device 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 interaction with the ultrasound guided catheter due to the mildly calcified and mildly tortuous anatomy and/or a coagulation of blood/contrast on the guide wire resulted in the reported difficult to advance and the reported difficult to remove.Inadvertent mishandling and/or interaction with the mildly calcified and mildly tortuous anatomy resulted in the noted multiple core bends likely contributing to the reported difficulties.The reported peeled / delaminated was unable to be 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.D9 - device available for evaluation updated from no to yes.Correction to h6: component code 4755 removed; 4721 added.Type of investigation code 4114 removed; 10 added.

• 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: 17908948
• Report Number: 2024168-2023-11152
• Device Sequence Number: 15320442
• Product Code: DQX
• UDI-Device Identifier: 08717648118777
• UDI-Public: (01)08717648118777(17)240831(10)2092071
• Combination Product (Y/N): N
• Initial Reporter Country: BR
• 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
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 06/10/2024

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: 08/31/2024
• Device Catalogue Number: 1009666J
• Device Lot Number: 2092071
• 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: 09/21/2023
• Supplement Date Received by Manufacturer: 04/03/2024; 05/21/2024
• Initial Report FDA Received Date: 10/10/2023
• Supplement Report FDA Received Date: 04/04/2024; 06/10/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/20/2022
• 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
• Concomitant Medical Products and Therapy/Usage Dates: ULTRA-SOUND GUIDED CATHETER
• Patient Sex: Female