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

Model Number	1001782J-HC
Medical Device Problem Code	Peeled/Delaminated (1454)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/14/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device is expected to be returned for investigation.It has not yet been received.A follow-up report will be submitted with all additional relevant information.Date of event is estimated.Medwatch report #mw5106146.
Event or Problem Description
User facility medwatch report received that states "abbott hi-torque balance middleweight guide wire used during cerebral thrombectomy was damaged and unusable during case.Coating peeled off wire prior to it's use.Impaired and packaging saved for manufacturer inspection.Fda safety report id #(b)(4)." no additional information was provided.
Event or Problem Description
Subsequent to the initially filed report, the following information was received: the peeling of the coating was noted prior to use; and therefore the guide wire was not used in the patient.There was no patient involvement.No additional information was provided.
Additional Manufacturer Narrative
A visual inspection was performed on the returned guide wire; however, the reported peeling was unable to be 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 similar incidents and/or complaints reported from this lot.Factors that may contribute to coating peeling during the procedure may include but not limited to mishandling of the device during manufacturing, preparation, device interactions or patient anatomical conditions.The investigation was unable to determine a conclusive cause for the reported peeling.There was noted guide wire damages found during returned device analysis which likely occurred during packing for returned analysis.There is no indication of a product quality issue with respect to the design, manufacture, or labeling of the device.Health effect - impact code 2199 removed.

• 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: 13570159
• Report Number: 2024168-2022-01786
• Device Sequence Number: 5913477
• Product Code: DQX
• UDI-Device Identifier: 08717648026010
• UDI-Public: 08717648026010
• Combination Product (Y/N): N
• Initial Reporter State: KY
• 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,User Facility,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 04/14/2022

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: 10/31/2022
• Device Model Number: 1001782J-HC
• Device Catalogue Number: 1001782J-HC
• Device Lot Number: 0111272
• 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: 01/31/2022
• Supplement Date Received by Manufacturer: 03/21/2022
• Initial Report FDA Received Date: 02/21/2022
• Supplement Report FDA Received Date: 04/14/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/12/2020
• 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