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

Model Number	1001780
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	08/01/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the procedure was to treat a bifurcation lesion in the left anterior descending (lad) artery with moderate to heavy calcification and >70% stenosis.After implantation of the stent, the hi-torque (ht) balance middle weight (bmw) guide wire became jailed and when pulled back, the guide wire became trapped.It was noted to be uncoiled [unraveled] and the tip separated inside the anatomy.The procedure was done under fluoroscopy but no cine images were taken.Attempted to snare the separated tip but was unsuccessful and was left in the body.No final images were taken of the material left in the patient.There was no clinically significant delay in the procedure.Returned device analysis identified that an additional ht bmw guide wire was returned unraveled and tip separated.The separated tip was not returned therefore there is a possibility that the separated tip remains in the patient anatomy.Follow-up with the site was performed; however, no additional information was provided.(therefore, the bmw guidewire is being reported under this medwatch report.).
Additional Manufacturer Narrative
The device was returned for analysis.There was no reported device issues; however the guide wire core and coil were noted separated and not returned.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.As there is no specific information on this complaint a conclusive cause for the noted damages (separated core/coil, stretched coils) cannot be determined.There is no indication of a product quality issue with respect to manufacture, design or labeling.The additional bmw 014 guidewire referenced is being filed under a separate medwatch report number.

• 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: 15523674
• Report Number: 2024168-2022-10189
• Device Sequence Number: 14080163
• Product Code: DQX
• UDI-Device Identifier: 08717648013836
• UDI-Public: 08717648013836
• Combination Product (Y/N): N
• Initial Reporter State: IN
• 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
• Report Date (Section B): 09/30/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Expiration Date: 04/30/2024
• Device Model Number: 1001780
• Device Catalogue Number: 1001780
• Device Lot Number: 2052171
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/07/2022
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 09/21/2022
• Initial Report FDA Received Date: 10/01/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/21/2022
• 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
• Outcome Attributed to Adverse Event: Other
• Patient Age: 71 YR
• Patient Sex: Male