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

Model Number 1009664J

Device Problems Break (1069); Difficult to Insert (1316); Difficult to Remove (1528); Difficult to Advance (2920)

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

Event Date 07/07/2022

Event Type  malfunction  

Event Description

It was reported that the procedure was to treat a lesion located in an unspecified vessel.Two hi torque balance middleweight universal ii guide wires from the same lot, were used in the same case.During use of balloon catheters and intravascular ultrasound (ivus) catheters, resistance was noted with the wire during insertion and removal over the wire.Upon removal of the wires, the wires were noted to be separated.There was no reported adverse patient effect and no clinically significant delay in the procedure.No additional information was provided.

Manufacturer Narrative

The device was received.Investigation is not yet complete.A follow-up report will be submitted with all additional relevant information.The other ht balance middleweight universal ii guide wire referenced is filed under a separate medwatch report number.

Manufacturer Narrative

The device was returned for analysis.The reported difficult to insert was able to be confirmed.The reported difficult to remove was able to be confirmed.The reported break was unable to be confirmed however there were noted damage (kinked core, bent shaping ribbon).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 did not indicate a lot specific quality issue.As there was no reported damage noted to the device during the inspection prior to use, the investigation determined the reported difficulties appear to be related to circumstances of the procedure as it is likely that inadvertent mishandling resulted in the noted guide wire damages (kinked core, bent shaping ribbon) thus resulting in the reported/noted difficult to insert and the reported/noted difficult to remove.The reported break was unable to be confirmed.There is no indication of a product quality issue with respect to manufacture, design or labeling.H6: medical device problem code 2920 - removed.

• Brand Name: HI-TORQUE BALANCE MIDDLEWEIGHT UNIVERSAL II GUIDE WIRE
• 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: 15161647
• MDR Text Key: 298212189
• Report Number: 2024168-2022-08547
• Device Sequence Number: 1
• Product Code: DQX
• UDI-Device Identifier: 08717648118753
• UDI-Public: 08717648118753
• Combination Product (y/n): N
• Reporter Country Code: CA
• PMA/PMN Number: K072460
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 08/31/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/03/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 02/29/2024
• Device Model Number: 1009664J
• Device Catalogue Number: 1009664J
• Device Lot Number: 2032271
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/02/2022
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/11/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/22/2022
• 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