MAUDE Adverse Event Report: ABBOTT VASCULAR 014 HT WINN GUIDE WIRE

Model Number	1012469
Medical Device Problem Codes	Peeled/Delaminated (1454); Difficult to Remove (1528)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/17/2021
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the procedure was to treat an unspecified lesion in the anterior tibial artery.While trying to remove the device from the anatomy, resistance was felt with the microcatheter and the coating on the winn guide wire stripped off inside of the microcatheter.The guide wire and the microcatheter had to be removed as a single unit.No coating stripped off in the anatomy, as it remained inside of the microcatheter.There was no adverse patient effect and no clinically significant delay during the procedure.No additional information was provided.
Additional Manufacturer Narrative
The device was received.Investigation is not yet complete.A follow-up report will be submitted with all additional relevant information.
Additional Manufacturer Narrative
The guide wire was returned and investigated.It was noted that the core was separated, the polymer coating was separated and there was bunching on the polymer coating.A portion of the polymer on the distal end of the polymer coating separation was pulled and folded over distally over the polymer coated core, confirming the reported peeling.There was tears sporadically 21cm distal to end of the proximal polymer coating for a length of 3cm.There were multiple bends and kinks in the entire length of the core.The reported difficult to remove and peeling were 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 incidents from this lot.There was no damage noted to the guide wire during the inspection prior to use which suggests a product quality issue with respect to manufacture, design or labeling did not contribute to the reported difficulties.Factors that may contribute to the difficulty to remove the guide wire and cause resistance between the devices may include, but not limited to, manufacturing, device placement technique, guiding catheter support, anatomical conditions/patient anatomical morphology, inner diameter of guide wire lumen or delivery device, outer diameter of the guide wire, condition of the guide wire, condition of the delivery/guiding catheter device, coagulation of blood or procedural contaminates.Additionally, possible factor that may contribute to guide wire breaks/separations can be affected by numerous factors including, but not limited to, manufacturing, guide wire damage, guide wire re-insertions, handing/manipulation, tensile or torsional loads beyond its design limits, entanglement with other devices or anatomical conditions.Based on the limited information provided by the account, the investigation was unable to determine a conclusive cause for the reported difficulty to remove, peeling and noted separations and polymer damages.There is no indication of a product quality issue with respect to the design, manufacture, or labeling of the device.

• Brand Name: 014 HT WINN 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: 12985034
• Report Number: 2024168-2021-11494
• Device Sequence Number: 5352390
• Product Code: DQX
• UDI-Device Identifier: 08717648156847
• UDI-Public: 08717648156847
• Combination Product (Y/N): N
• Initial Reporter State: IL
• Initial Reporter Country: US
• PMA/510(K) Number: K101648
• 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): 02/09/2022

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: 07/31/2023
• Device Model Number: 1012469
• Device Catalogue Number: 1012469
• Device Lot Number: 1080971
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/07/2021
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 11/19/2021
• Supplement Date Received by Manufacturer: 02/07/2022
• Initial Report FDA Received Date: 12/13/2021
• Supplement Report FDA Received Date: 02/09/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/09/2021
• 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
• Patient Age: 67 YR
• Patient Sex: Male