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

Model Number	1009660J
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/28/2021
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the procedure was to treat a moderately calcified and moderately tortuous vessel in the right coronary artery (rca).The hi-torque (ht) balance middleweight (bmw) universal guide wire was attempted to be advanced without resistance, however, it was found by fluoroscopy that the guide wire tip was fractured.The ht bmw was withdrawn and another bmw was used to complete the procedure.There was no resistance during withdrawal.There was no reported adverse patient effect and there was no significant delay in the procedure.No additional information was provided.
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.
Additional Manufacturer Narrative
A visual inspection was performed on the returned guide wire; however, the reported tip break 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.The investigation determined the reported tip break and noted tip damages appear to be related to case circumstances of the procedure.In this case, based on the reported information and returned device analysis, it is likely that during the procedure, the coils stretched and became offset against the anatomy causing the appearance of a break under fluoroscopy.The noted bend on the shaping ribbon is consistent with the pre-tip shape on the guide wire.The noted teflon coating damage likely occurred during retraction through the torque device and /or other accessory devices used in the procedure.There is no indication of a product quality issue with respect to the design, manufacture, or labeling of the device.

• Brand Name: HI-TORQUE BALANCE MIDDLEWEIGHT UNIVERSAL 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: 12807778
• Report Number: 2024168-2021-10333
• Device Sequence Number: 4778104
• Product Code: DQX
• UDI-Device Identifier: 08717648065866
• UDI-Public: 08717648065866
• Combination Product (Y/N): N
• Initial Reporter Country: CO
• PMA/510(K) Number: K101011
• 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
• Report Date (Section B): 01/10/2022

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: 03/31/2023
• Device Model Number: 1009660J
• Device Catalogue Number: 1009660J
• Device Lot Number: 1040673
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/14/2021
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 10/22/2021
• Supplement Date Received by Manufacturer: 12/27/2021
• Initial Report FDA Received Date: 11/12/2021
• Supplement Report FDA Received Date: 01/10/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/06/2021
• 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 Sex: Unknown