MAUDE Adverse Event Report: ABBOTT VASCULAR HT BALANCE GUIDE WIRE

Model Number	1001780
Medical Device Problem Codes	Difficult to Remove (1528); Material Separation (1562); Improper or Incorrect Procedure or Method (2017)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	01/06/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The device was returned.Investigation is not yet complete.A follow up report will be submitted with all additional relevant information.(b)(4).
Event or Problem Description
It was reported that the procedure was performed to treat a lesion in the non-tortuous, moderately calcified, 70% stenosed distal left anterior descending coronary artery.A balance middleweight (bmw) guide wire was advanced without resistance, and the bmw was used at the same time as a non-abbott stent, a non-abbott balloon, and another bmw guide wire.During removal, the bmw faced resistance with the anatomy, so force was applied.The tip of the guide wire separated and remains floating in the patient's anatomy.No treatment was performed, the procedure was completed, and the patient is fine.There was no reported 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, and the reported separation was confirmed.The reported difficulty to remove was unable to be replicated in a testing environment as it was based on operational circumstances.It should be noted that the instructions for use for the guide wire hi-torque guide wires ce, states: carefully observe the instructions under ¿do not¿ and ¿do¿ below.Failure to do so may result in vessel trauma, guide wire damage, guide wire tip separation, or stent damage.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 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.The investigation determined the reported difficulty to remove and guide wire tip separation appear to be related to operational circumstances of the procedure.There is no indication of a product quality issue with respect to the design, manufacture, or labeling of the device.

• Brand Name: HT BALANCE GUIDE WIRE
• Common Device Name: GUIDE WIRE
• Manufacturer (Section D): ABBOTT VASCULAR; 26531 ynez rd.; temecula CA 92591 4628
• MDR Report Key: 9631664
• Report Number: 2024168-2020-00895
• Device Sequence Number: 2757091
• Product Code: DQX
• UDI-Device Identifier: 08717648013836
• UDI-Public: 08717648013836
• Combination Product (Y/N): N
• Initial Reporter Country: IT
• PMA/510(K) Number: K021228
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 04/01/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 06/30/2021
• Device Model Number: 1001780
• Device Catalogue Number: 1001780
• Device Lot Number: 9072671
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/23/2020
• Initial Date Received by Manufacturer: 01/07/2020
• Supplement Date Received by Manufacturer: 03/09/2020
• Initial Report FDA Received Date: 01/27/2020
• Supplement Report FDA Received Date: 04/01/2020
• 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: BMW GUIDE WIRE; BMW GUIDE WIRE
• Outcome Attributed to Adverse Event: Other