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

Model Number	1011880J
Medical Device Problem Codes	Difficult to Insert (1316); Peeled/Delaminated (1454)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/01/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device is expected to be returned for evaluation.It has not yet been received.A follow-up report will be submitted with all additional relevant information.
Event or Problem Description
It was reported that the procedure was performed to treat a lesion in the right coronary artery.A balance middleweight elite guide wire was attempted to be inserted into an unspecified balloon catheter; however, there was difficulty and the core was peeling.Another bmw elite guide wire was used to successfully complete the procedure.There were no adverse patient effects and no clinically significant delay in the procedure.No additional information was provided.
Additional Manufacturer Narrative
A visual inspection and dimensional/functional testing were performed on the returned guide wire and the reported difficulty to insert was confirmed.The repotted 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 reported from this lot.The investigation was unable to determine a conclusive cause for the reported difficulty to insert and core peeling.Based on the limited information provided by the account and returned device analysis, it may be possible that the coils became damaged during preparation resulting in the reported difficulty to insert.Additionally, it is possible that the core dragged against the torque device and or other accessory device used in the procedure causing the teflon coating to scratch off and the appearance of peeling; however, these could not be confirmed.The noted bends on the guide wire likely occurred during packing for return analysis.There is no indication of a product quality issue with respect to the design, manufacture.

• Brand Name: HI-TORQUE BALANCE MIDDLEWEIGHT ELITE GUIDE WIRE
• Common Device Name: GUIDE WIRE
• Manufacturer (Section D): ABBOTT VASCULAR; 26531 ynez rd.; temecula CA 92591 4628
• MDR Report Key: 11700786
• Report Number: 2024168-2021-03347
• Device Sequence Number: 11646427
• Product Code: DQX
• UDI-Device Identifier: 08717648144790
• UDI-Public: 08717648144790
• Combination Product (Y/N): N
• Initial Reporter Country: PL
• PMA/510(K) Number: K103101
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 06/21/2021

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: 09/30/2022
• Device Model Number: 1011880J
• Device Catalogue Number: 1011880J
• Device Lot Number: 0102661
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/22/2021
• Initial Date Received by Manufacturer: 04/01/2021
• Supplement Date Received by Manufacturer: 06/01/2021
• Initial Report FDA Received Date: 04/21/2021
• Supplement Report FDA Received Date: 06/21/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1