MAUDE Adverse Event Report: ABBOTT VASCULAR ACS HI-TORQUE BALANCE MIDDLEWEIGHT GUIDE WIRE WITH HYDROCOAT HYDROPHILIC COATI

Model Number	1001780
Medical Device Problem Code	Difficult to Remove (1528)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	03/10/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device is expected to be returned for investigation.It has not yet been received.A follow-up report will be submitted with all additional relevant information.
Event or Problem Description
It was reported that the procedure was performed to treat a non-calcified, moderately tortuous distal right coronary artery.The balance middleweight guidewire was advanced without issue.During removal, resistance was felt with the optical coherence tomography (oct) dragonfly opstar imaging catheter.The guidewire, oct catheter, and guide catheter all had to be removed together as a single unit.A new bmw was used to successfully complete the procedure.Per the physician, the patient was moving a lot throughout the entire procedure.There were no adverse patient effects and no clinically significant delay in the procedure.No additional information was provided.
Additional Manufacturer Narrative
Visual and dimensional inspections were performed on the returned guide wire.The reported difficulty to remove was unable to be confirmed due to the returned condition of the guide wire.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 and/or complaints reported from this lot.There was no damage noted to the guide wire during the inspection prior to use which suggests a product quality issue with respect to manufacture, design or labeling did not contribute to the reported difficulties.Factors that may contribute to the difficulty to remove the guide wire and cause resistance between the devices may include, but not limited to, manufacturing, device placement technique, guiding catheter support, anatomical conditions/patient anatomical morphology, inner diameter of guide wire lumen or delivery device, outer diameter of the guide wire, condition of the guide wire, condition of the deliver device, coagulation of blood and/or procedural contaminates.The investigation was unable to determine a conclusive cause for the reported difficulty to remove.The noted bend on the tip appears to be consistent with the tip shape process prior to use.The noted kinks on the core likely occurred during packing for return analysis.There is no indication of a product quality issue with respect to the design, manufacture, or labeling of the device.

• Brand Name: ACS HI-TORQUE BALANCE MIDDLEWEIGHT GUIDE WIRE WITH HYDROCOAT HYDROPHILIC COATI
• Common Device Name: GUIDE WIRE
• Manufacturer (Section D): ABBOTT VASCULAR; 26531 ynez rd.; temecula CA 92591 4628
• MDR Report Key: 11592371
• Report Number: 2024168-2021-02529
• Device Sequence Number: 3683929
• Product Code: DQX
• UDI-Device Identifier: 08717648013836
• UDI-Public: 08717648013836
• Combination Product (Y/N): N
• Initial Reporter State: NY
• Initial Reporter Country: US
• PMA/510(K) Number: K021228
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 06/04/2021

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: 10/31/2022
• Device Model Number: 1001780
• Device Catalogue Number: 1001780
• Device Lot Number: 0113073
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/23/2021
• Initial Date Received by Manufacturer: 03/10/2021
• Supplement Date Received by Manufacturer: 05/19/2021
• Initial Report FDA Received Date: 03/30/2021
• Supplement Report FDA Received Date: 06/04/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: DRAGONFLY OPSTAR IMAGING CATHETER