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

Model Number 1009664

Device Problems Difficult to Insert (1316); Material Separation (1562)

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

Event Date 09/16/2022

Event Type  malfunction  

Manufacturer Narrative

A visual inspection was performed on the returned device.The reported difficult to insert could not be tested as it was based on operational context.Additionally, the core was noted to be separated at the distal end of the hypotube.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/complaints from this lot.The investigation was unable to determine a conclusive cause for the reported difficult to insert.Factors that may contribute to a difficulty inserting the guide wire into the balloon dilatation catheter include, but are not limited to, buildup of procedural contaminants, interaction with the guide catheter during insertion, outer diameter of the guide wire, inner diameter of the catheter, damage to the guide wire, and/or damage to the catheter.In this case, the investigation was unable to determine a conclusive cause for the reported difficulty inserting the guide wire through the balloon dilatation catheter; however, there was no damage noted to the guide wire during the inspection prior to use or during preparation for use which suggests a product quality issue did not contribute to the reported difficulty.Additionally, it is likely that manipulation of the device, when resistance was encountered, resulted in the damages noted during return analysis; material separation (core), material deformation (misaligned coils), twisted core, scratched teflon, and kinked core.There is no indication of a product quality issue with respect to manufacture, design, or labeling.The nc trek referenced is filed under 2024168-2022-10349.

Event Description

It was reported that the procedure was to treat a lesion located in the mid-left anterior descending coronary artery that was non calcified and non tortuous.The lesion was pre dilated with an 3.5x12 nc trek and a 3.5 x 38 xience skypoint was deployed.Post dilatation was attempted with a 3.5x12mm nc trek; however, the ht balance middleweight universal ii guide wire (gw) met resistance coming out of nc trek at the tip of the catheter.The entire unit was pulled into the guide catheter, but the gw split the rapid exchange port on the catheter.All was successfully retrieved with no intervention.There was no reported adverse patient effect and no clinically significant delay in the procedure.The lesion was re-wired with a non-abbott guide wire and a new nc trek was advanced to post-dilate the stent.Device analysis revealed the guide wire distal core was separated.No additional information was provided.

• 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: 15794614
• MDR Text Key: 306288092
• Report Number: 2024168-2022-11562
• Device Sequence Number: 1
• Product Code: DQX
• UDI-Device Identifier: 08717648118715
• UDI-Public: 08717648118715
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K072460
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 11/14/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/14/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 1009664
• Device Catalogue Number: 1009664
• Device Lot Number: 2062072
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/13/2022
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/24/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/20/2022
• 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
• Patient Age: 59 YR
• Patient Sex: Male
• Patient Weight: 88 KG