MAUDE Adverse Event Report: ABBOTT VASCULAR HT VERSATURN; GUIDE WIRE

Model Number	1013319J
Medical Device Problem Codes	Break (1069); Difficult to Advance (2920)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	08/10/2020
Type of Reportable Event	Serious Injury
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 this was a case to treat the left anterior descending artery.The high torque versaturn guide wire (gw) was inserted; however, resistance was felt.The gw was slightly pulled, but it was noticed that the gw had broken.To recover the broken piece, a snare was inserted.There was no clinically significant delay i the procedure.No additional information was provided.
Additional Manufacturer Narrative
Visual and dimensional analysis was performed on the returned device.The separation was confirmed.The difficulty advancing could not be tested due to the 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 incidents.The investigation determined for the reported difficulty advancing and separation were due to the circumstances of the procedure.It is likely that the wire may have been damaged during the insertion process resulting in separation.There is no indication of a product quality issue with respect to the design, manufacture, or labeling of the device.D4: correction - catalog number and lot number.

• Brand Name: HT VERSATURN
• Common Device Name: GUIDE WIRE
• Manufacturer (Section D): ABBOTT VASCULAR; 26531 ynez rd.; temecula CA 92591 4628
• MDR Report Key: 10487958
• Report Number: 2024168-2020-07331
• Device Sequence Number: 2925587
• 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
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 11/11/2020

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: 04/30/2022
• Device Model Number: 1013319J
• Device Catalogue Number: 1013317J
• Device Lot Number: 0052061
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/05/2020
• Initial Date Received by Manufacturer: 08/10/2020
• Supplement Date Received by Manufacturer: 10/21/2020
• Initial Report FDA Received Date: 09/03/2020
• Supplement Report FDA Received Date: 11/11/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention