MAUDE Adverse Event Report: ABBOTT VASCULAR INC. HI-TORQUE BALANCE MIDDLEWEIGHT UNIVERSAL; WIRE, GUIDE, CATHETER

Model Number	1009660
Medical Device Problem Codes	Difficult to Remove (1528); Material Separation (1562); Material Too Soft/Flexible (4007)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/14/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Manufacturer's investigation is still pending at this time.Results and conclusions will be provided in the final report.The dragonfly opstar imaging catheter device referenced in b5 is filed under a separate medwatch report number.
Event or Problem Description
It was reported that the procedure was to treat a lesion in the mid left anterior descending (lad).The bmw universal guidewire was advanced to the distal lad and into a small diagonal branch.The dragonfly opstar imaging catheter was advanced and an optical coherence tomography (oct) run was obtained.When removing the oct catheter, the guidewire was unintentionally withdrawn with the dragonfly catheter to the point that the coil of the guidewire was inside the rapid exchange portion of the dragonfly catheter and the guidewire tip was observed to have separated.A fluoroscope was used to locate the separated tip, it was retained inside the proximal shaft of the guiding catheter and inside the hemostatic valve.The hemostatic valve with the coil tip in it, were removed.It is believed that when the dragonfly catheter was removed the bmw coil prolapsed, and became entangled in the dragonfly catheter.When the doctor withdrew the dragonfly catheter, the guidewire withdrew with it, all the way into the guide catheter.When the dragonfly catheter was removed from the hemostatic valve, the coil of the wire separated and remained inside the guide catheter.There was no clinically significant delay in the procedure and no adverse patient effects.No additional information was provided.
Additional Manufacturer Narrative
The device was not returned for evaluation.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 similar incidents and/or complaints from this lot.Based on the information provided, the reported difficulties appear to be due to procedural circumstances.It is likely that during the procedure, the clearance between the bmw universal guidewire and dragonfly opstar imaging catheter was reduced causing the devices to become stuck together.When the dragonfly catheter was withdrawn, the guidewire was unintentionally withdrawn with the dragonfly catheter causing the tip of the guidewire to prolapse and separate in the guide catheter.There is no indication of a product quality issue with respect to the design, manufacture, or labeling of the device.D4 - correction - catalog # and lot # updated.
Additional Manufacturer Narrative
H2: updated the device identification fields to align with the information in the corresponding fields in gudid.

• Brand Name: HI-TORQUE BALANCE MIDDLEWEIGHT UNIVERSAL
• Common Device Name: WIRE, GUIDE, CATHETER
• Manufacturer (Section D): ABBOTT VASCULAR INC.; 3200 lakeside drive; santa clara CA 95054 2807
• 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: 17869544
• Report Number: 2024168-2023-10835
• Device Sequence Number: 7601580
• Product Code: DQX
• UDI-Device Identifier: 08717648014338
• UDI-Public: (01)08717648014338(17)250630(10)3071771
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K152709
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 06/24/2024

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 Expiration Date: 06/30/2025
• Device Model Number: 1009660
• Device Catalogue Number: 1009660
• Device Lot Number: 3071771
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 09/14/2023
• Supplement Date Received by Manufacturer: 10/25/2023; 06/13/2024
• Initial Report FDA Received Date: 10/04/2023
• Supplement Report FDA Received Date: 10/30/2023; 06/24/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 07/17/2023
• 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 Age: 49 YR
• Patient Sex: Female
• Patient Weight: 100 KG