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

Model Number	1001782
Medical Device Problem Codes	Entrapment of Device (1212); Material Separation (1562); Stretched (1601); Improper or Incorrect Procedure or Method (2017); Device Damaged by Another Device (2915)
Health Effect - Clinical Code	Device Embedded In Tissue or Plaque (3165)
Date of Event	08/01/2022
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).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.
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 it was 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.No additional information was provided.
Additional Manufacturer Narrative
The device was returned for analysis.The reported material separation was able to be confirmed.The reported stretched coils was able to be confirmed.The reported entrapment of device and the reported device damaged by another device were unable to be replicated in a testing environment as they were based on operational circumstances.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.Reportedly, 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 should be noted that the hi-torque guide wires instructions for use (ifu) states: do not: push, auger, withdraw or torque a guide wire that meets resistance.Although the guide wire was pulled back, this was due to the guidewire being jailed therefore attempting to pull back the device seemed to be a reasonable clinical response to the difficulties as there was no reported damage noted to the device during the inspection prior to use, the investigation determined the reported difficulties appear to be related to circumstances of the procedure as it is likely that after implantation of the stent, the guide wire inadvertently became jailed resulting in the reported entrapment of device.Interaction/manipulation of the compromised device resulted in the reported device damaged by another device, the reported/noted device damages (stretched/offset coils, bent shaping ribbon) and ultimately resulted in the reported/noted separations (shaping ribbon, tip coil).There is no indication of a product quality issue with respect to manufacture, design or labeling.

• Brand Name: ACS HI-TORQUE BALANCE MIDDLEWEIGHT 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: 15311022
• Report Number: 2024168-2022-09206
• Device Sequence Number: 11411875
• Product Code: DQX
• UDI-Device Identifier: 08717648013843
• UDI-Public: 08717648013843
• 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,Followup
• Report Date (Section B): 09/29/2022

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?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 09/30/2023
• Device Model Number: 1001782
• Device Catalogue Number: 1001782
• Device Lot Number: 1102271
• 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: 08/08/2022
• Supplement Date Received by Manufacturer: 09/28/2022
• Initial Report FDA Received Date: 08/29/2022
• Supplement Report FDA Received Date: 09/30/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/22/2021
• 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
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 71 YR
• Patient Sex: Male