MAUDE Adverse Event Report: ABBOTT VASCULAR HI-TORQUE WHISPER MS GUIDE WIRE

Model Number	1005359H
Medical Device Problem Codes	Entrapment of Device (1212); Material Separation (1562); Improper or Incorrect Procedure or Method (2017); Failure to Advance (2524)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	01/13/2022
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The device was discarded and will not be returned for evaluation.The 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 on (b)(6) 2022, a percutaneous intervention was performed on the right anterior tibial (at) with a chronic total occlusion and no blood flow.The whisper guide wire failed to cross the cto lesion.During removal, the device was stuck in the calcification and the polymer jacket separated from the device.It was decided to leave the separated portion in the calcification without any additional treatment/intervention performed to remove the separated portion.Another device was used in replacement.There was no adverse patient sequela and there was no clinically significant delay.No additional information was provided regarding this issue.
Additional Manufacturer Narrative
H6: medical device problem code 2017 failure to follow instructions.The device 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.It should be noted that instructions for use guide wire hi-torque guide wires warning section, states: 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.The investigation determined the reported failure to advance, entrapment, separation, and foreign body in the patient appear to be related user error.In this case, it is likely that the technique and/or manipulation during advancement caused the tip of the guide wire to get stuck or trapped in the calcification.Manipulation against resistance ultimately resulted in the polymer separation in in the anatomy.It was decided to leave the separated portion in the calcification without any additional treatment/intervention performed to remove the separated portion.There is no indication of a product quality issue with respect to manufacture, design, or labeling.

• Brand Name: HI-TORQUE WHISPER MS 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: 13472517
• Report Number: 2024168-2022-01230
• Device Sequence Number: 11934692
• Product Code: DQX
• UDI-Device Identifier: 08717648037825
• UDI-Public: 08717648037825
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: K101116
• 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): 03/08/2022

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: 1005359H
• Device Catalogue Number: 1005359H
• Device Lot Number: 1102071
• 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: 01/14/2022
• Supplement Date Received by Manufacturer: 02/15/2022
• Initial Report FDA Received Date: 02/07/2022
• Supplement Report FDA Received Date: 03/08/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 10/20/2021
• 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: Other
• Patient Age: 57 YR
• Patient Sex: Male
• Patient Weight: 123 KG