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

Model Number	1005357H
Medical Device Problem Codes	Material Separation (1562); Improper or Incorrect Procedure or Method (2017); Failure to Advance (2524)
Health Effect - Clinical Code	Device Embedded In Tissue or Plaque (3165)
Date of Event	03/23/2021
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.(b)(4).
Event or Problem Description
User facility medwatch report received that states: [during the procedure the tip of the whisper broke off and was left in patient as risks outweighed benefits to retrieve wire fragment].On 4/21/2021: additional information received today from the account stating that the procedure was to treat a left iliac artery.There was resistance with the anatomy while advancing the guide wire when the tip broke off.A stent was used to embed/crush the tip.No additional information was provided.
Additional Manufacturer Narrative
Device code 2017 - against resistance.The product was not returned to abbott vascular for analysis.A review of the electronic lot history record (elhr), corrective action tracking system for the web (catsweb) database review and similar incident query for this product were not performed since the lot number was not reported.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 should be noted that the electronic instructions for use (ifu) for hi-torque guide wires ce/fda warnings section, state: 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, the ifu violation of torqueing the guide wire against resistance resulting in the tip separation and embedding of the device in the vessel or plaque does appear to have caused or contributed to the reported complaint.The investigation determined the reported failure to advance, torqueing the guide wire against resistance, tip separation and subsequent treatment appears to be related to user error.In this case, the torqueing against resistance with the occluded anatomy likely caused damage to the tip resulting in the tip separation and subsequent treatment.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
• MDR Report Key: 11729235
• Report Number: 2024168-2021-03546
• Device Sequence Number: 11622463
• Product Code: DQX
• UDI-Device Identifier: 08717648037801
• UDI-Public: 08717648037801
• Combination Product (Y/N): N
• Initial Reporter State: PA
• 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: user facility
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 05/04/2021

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 Model Number: 1005357H
• Device Catalogue Number: 1005357H
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 04/16/2021
• Supplement Date Received by Manufacturer: 04/29/2021
• Initial Report FDA Received Date: 04/26/2021
• Supplement Report FDA Received Date: 05/04/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 76 YR
• Patient Weight: 60