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

Model Number	1009665
Medical Device Problem Codes	Entrapment of Device (1212); Material Separation (1562); Improper or Incorrect Procedure or Method (2017)
Health Effect - Clinical Code	Device Embedded In Tissue or Plaque (3165)
Date of Event	09/13/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The customer reported the device is not returning.Investigation is not yet complete.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 the right superficial femoral artery with moderate calcification, 90% stenosis.The balance middleweight (bmw) universal ii guide wire was advanced but the tip became caught behind an existing stent and about 5 cm separated.The tip was not able to be snared so it was crushed to the vessel using an unspecified 6.0.60x80 self expanding stent.There were no adverse patient sequela.No additional information was provided.
Additional Manufacturer Narrative
The product was not returned to abbott vascular for analysis.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 and/or complaints reported from this lot.There was no damage noted to the guide wire during the inspection prior to use which suggests a product quality issue with respect to manufacture, design or labeling did not contribute to the reported difficulties.It was reported that the procedure was to treat the right superficial femoral artery with moderate calcification, 90% stenosis.The balance middleweight (bmw) universal ii guide wire was advanced, but the tip became caught behind an existing stent and about 5 cm separated.The tip was not able to be snared so it was crushed to the vessel using an unspecified 6.0.60x80 self-expanding stent.It should be noted that instructions for use (ifu) guide wire hi-torque guide wires for ptca, pta stents, with ce: carefully observe the instructions under ¿do not¿ and ¿do¿ below.Failure to do so may result in vessel trauma, guide wire damage, guide wire tip separation, or stent damage.If resistance is observed at any time, determine the cause under fluoroscopy and take remedial action as needed.Do not push, auger, withdraw, or torque a guide wire that meets resistance.Do not torque a guide wire if the tip becomes entrapped within the vasculature.In this case, based on the reported information the reported ifu violation does appear to have caused or contributed to the reported complaint.It is likely that the technique and/or manipulation during advancement resulted in the entrapment of the device behind the previously implanted stent.Further manipulation against resistance ultimately resulted in the tip separation and embedding of the tip in the vessel.The investigation determined the reported entrapment of the device, tip separation, unexpected medical intervention/additional therapy non-surgical intervention and embedding of the device in the vessel appear to be related to user error.It is likely that the technique and/or manipulation during advancement resulted in the entrapment of the device behind the previously implanted stent.Further manipulation against resistance ultimately resulted in the tip separation and the embedding of the tip in the vessel with a self-expanding stent.There is no indication of a product quality issue with respect to manufacture, design, or labeling.
Event or Problem Description
It was reported that the procedure was to treat the right superficial femoral artery with moderate calcification, 90% stenosis.The balance middleweight (bmw) universal ii guide wire was advanced but the tip became caught behind an existing stent and about 5 cm separated.The tip was not able to be snared so it was crushed to the vessel using an unspecified 6.0.60x80 self expanding stent.There were no adverse patient sequela.Subsequent to the initially filed report the following information was provided: the bmw guide wire reached the lesion but there was resistance with the previously implanted stent.There was no resistance during removal.
Event or Problem Description
N/a.
Additional Manufacturer Narrative
Subsequent to filing the initial reports, patient information was received.A1-a4 has been updated.

• Brand Name: HI-TORQUE BALANCE MIDDLEWEIGHT UNIVERSAL II 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: 12608792
• Report Number: 2024168-2021-09092
• Device Sequence Number: 1350436
• Product Code: DQX
• UDI-Device Identifier: 08717648118722
• UDI-Public: 08717648118722
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: K072460
• 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
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 12/16/2021

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: 01/31/2022
• Device Model Number: 1009665
• Device Catalogue Number: 1009665
• Device Lot Number: 0020371
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 09/23/2021
• Supplement Date Received by Manufacturer: 11/03/2021; 11/25/2021
• Initial Report FDA Received Date: 10/11/2021
• Supplement Report FDA Received Date: 11/22/2021; 12/16/2021
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 02/03/2020
• 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
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 72 YR
• Patient Sex: Female
• Patient Weight: 65 KG