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

Catalog Number	1005357HJ
Medical Device Problem Codes	Difficult to Remove (1528); Difficult to Advance (2920)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/01/2023
Type of Reportable Event	Malfunction
Additional 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 lot number was not provided.The investigation was unable to determine a conclusive cause for the reported difficult to advance/remove.There is no indication of a product quality issue with respect to manufacture, design, or labeling.The additional guide wires referenced in b5 are filed under separate medwatch report numbers.
Event or Problem Description
It was reported in a general comment that during procedures of greater complexity, the balance middleweight (bmw), bmw universal ii, balance heavyweight, whisper ms and whisper extra support guide wires lose their hydrophilicity.There is resistance with balloons, stents and imaging catheters and the guide wires are simply removed with the other device as a single unit because the devices are stuck to each other.There were no adverse patient effects and the length of the procedure is extended and there is greater exposure to x rays but there is no consequence to the patient.No additional information was provided.

• Brand Name: HI-TORQUE WHISPER GUIDE WIRES
• 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: 18144749
• Report Number: 2024168-2023-12736
• Device Sequence Number: 6875221
• Product Code: DQX
• UDI-Device Identifier: 08717648037818
• UDI-Public: 08717648037818
• Combination Product (Y/N): N
• Initial Reporter Country: BR
• 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: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 11/15/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Catalogue Number: 1005357HJ
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 11/15/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• 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
• Patient Sex: Unknown