MAUDE Adverse Event Report: ABBOTT VASCULAR ACS HI-TORQUE BALANCE MIDDLEWEIGHT GUIDE WIRE WITH HYDROCOAT HYDROPHILIC COATI

Model Number	1001782-HC
Medical Device Problem Codes	Difficult to Remove (1528); Stretched (1601); Material Twisted/Bent (2981)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/03/2022
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the procedure was to treat a right coronary artery.Post stenting of the target lesion and once the procedure was already completed, as the dragonfly opstar catheter was attempted to be removed, it became stuck on the balance middleweight guide wire.Both units were removed together from the anatomy without issue.The distal end of the guide wire was noted to be twisted and stretched.The tip of the dragonfly catheter was noted to be crushed/collapsed.There were no adverse patient effects and no clinically significant delay in the procedure.No additional information was provided.Returned device analysis of the dragonfly catheter revealed that the guide wire exit port was torn distally for a length of 5mm.The distal tip was torn and stretched and a portion of the distal tip was separated and not returned.Additional reported information indicates that the tip was intact when the dragonfly catheter was pulled back into the guide catheter and it was confirmed that no portion of the device remained in the patient anatomy.
Additional Manufacturer Narrative
The device was received.Investigation is not yet complete.A follow-up report will be submitted with all additional relevant information.The dragonfly opstar catheter referenced is filed under a separate medwatch report number.
Additional Manufacturer Narrative
Visual and dimensional analysis was performed on the returned device.The reported difficulty removing was unable to be confirmed due to the device condition.The damage to the guide wire was 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 identified no other complaints reported from this lot.The investigation determined that the difficulties were likely related to circumstances of the procedure.The torn guide wire exit port noted on the returned dragonfly catheter suggest that the guide wire and catheter were likely spread apart during removal causing the guide wire to tear into the exit port of the dragonfly resulting in difficulty removing and damage to the guide wire tip coils.There is no indication of a product quality issue with respect to the design, manufacture, or labeling of the device.

• Brand Name: ACS HI-TORQUE BALANCE MIDDLEWEIGHT GUIDE WIRE WITH HYDROCOAT HYDROPHILIC COATI
• 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: 13586735
• Report Number: 2024168-2022-01925
• Device Sequence Number: 19935941
• Product Code: DQX
• UDI-Device Identifier: 08717648025990
• UDI-Public: 08717648025990
• Combination Product (Y/N): N
• Initial Reporter State: GA
• Initial Reporter Country: US
• 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: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 03/24/2022

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: 09/30/2023
• Device Model Number: 1001782-HC
• Device Catalogue Number: 1001782-HC
• Device Lot Number: 1100171
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/10/2022
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 02/03/2022
• Supplement Date Received by Manufacturer: 03/02/2022
• Initial Report FDA Received Date: 02/23/2022
• Supplement Report FDA Received Date: 03/24/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/01/2021
• 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: DRAGONFLY CATHETER
• Patient Age: 61 YR
• Patient Sex: Male
• Patient Weight: 95 KG