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

Catalog Number UNK 014 WHISPER MS

Device Problems Difficult to Remove (1528); Difficult to Advance (2920)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 02/19/2024

Event Type  malfunction  

Manufacturer Narrative

D4 - the udi is unknown because the part/lot number were not provided.Manufacturer's investigation is still pending at this time.Results and conclusions will be provided in the final report.The additional whisper guide wires referenced in b5 are filed under separate medwatch report numbers.

Event Description

It was reported that the procedure was to treat an unspecified lesion.When the whisper guide wire was used, it became stuck with the balloons and ultrasound catheter, preventing advancement of the devices.This occurred with 5 other whisper guide wires.There were no reported adverse patient effects and there was no reported clinically significant delay in the procedure.No additional information was provided.

Manufacturer Narrative

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 were not performed because the part/lot numbers were not reported.The investigation was unable to determine a conclusive cause for the reported difficulties.Factors that may contribute to difficulty advancing/removing a catheter or ivus over the guide wire include, but are not limited to, inner diameter of the catheter/ivus, outer diameter of the guide wire, device support, buildup of procedural contaminants, user technique, and/or damage to the catheter/ivus or guide wire.Based on the information provided and because the device was not returned for analysis, it is unknown what may have caused the reported difficulty during advancement/removal.There is no indication of a product quality issue with respect to manufacture, design, or labeling; therefore, no product-related corrective action will be implemented in this case.Device available for evaluation updated from ni to no.

• Brand Name: HI-TORQUE WHISPER GUIDE WIRES
• Type of Device: 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: 18852218
• MDR Text Key: 337072989
• Report Number: 2024168-2024-02850
• Device Sequence Number: 1
• Product Code: DQX
• Combination Product (y/n): N
• Reporter Country Code: BR
• PMA/PMN Number: K101116
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative,Distributor
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 03/21/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/06/2024
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: UNK 014 WHISPER MS
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/20/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1