MAUDE Adverse Event Report: ABBOTT VASCULAR HT VERSATURN GUIDE WIRE

Model Number	1013319J
Medical Device Problem Codes	Break (1069); Difficult to Remove (1528); Stretched (1601)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/18/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device is expected to be returned for evaluation.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, non-tortuous left anterior descending artery.The high-torque versaturn f guidewire was advanced to the lesion.A non-compliant non-abbott balloon was advanced over the guidewire to the lesion then removed after dilatation was performed.Resistance was felt during the withdrawal of the balloon catheter over the guidewire.It was then observed via angiography that the coils were unraveled.The guidewire was removed very easily without complications.A new versaturn f guidewire was used to successfully complete the 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 and the reported break and stretched coils were confirmed.The reported difficulty to remove was unable to be confirmed due to the returned condition of the device.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 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, core break and stretched coils appear to be related to operational circumstances of the procedure.In this case, it is likely that manipulation during the procedure caused the tip core to kink and the difficulty to remove from the balloon catheter.Further manipulation against resistance ultimately resulted in the core break, stretched and misaligned coils during retraction.The noted teflon coating damage likely occurred during retraction through the torque device and or other accessory devices used in the procedure.There is no indication of a product quality issue with respect to manufacture, design, or labeling.

• Brand Name: HT VERSATURN GUIDE WIRE
• Common Device Name: GUIDE WIRE
• Manufacturer (Section D): ABBOTT VASCULAR; 26531 ynez rd.; temecula CA 92591 4628
• MDR Report Key: 11275853
• Report Number: 2024168-2021-00841
• Device Sequence Number: 3774109
• Product Code: DQX
• UDI-Device Identifier: 08717648198496
• UDI-Public: 08717648198496
• Combination Product (Y/N): N
• Initial Reporter Country: IT
• PMA/510(K) Number: K141782
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 08/18/2021

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: 07/31/2022
• Device Model Number: 1013319J
• Device Catalogue Number: 1013319J
• Device Lot Number: 0082671
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/22/2021
• Initial Date Received by Manufacturer: 01/18/2021
• Supplement Date Received by Manufacturer: 08/05/2021
• Initial Report FDA Received Date: 02/03/2021
• Supplement Report FDA Received Date: 08/18/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1