MAUDE Adverse Event Report: AV-TEMECULA-CT HI-TORQUE VERSACORE MODIFIED J GUIDE WIRE SYSTEM

Catalog Number	1012068-01
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	04/13/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).Evaluation summary: the device was returned for analysis.The reported stretched guide wire was able to be confirmed.The reported entrapment and the reported difficult to remove were unable to be replicated in a testing environment as they were based on operational circumstances.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 from this lot.The investigation determined the reported difficulties appear to be related to circumstances of the procedure.Interaction with the anatomy/other devices and/or manipulation of the device resulted in the noted multiple shaping ribbon bends and the reported/noted stretched coils.There is no indication of a product quality issue with respect to manufacture, design or labeling.
Event or Problem Description
It was reported that the diagnostic procedure was to treat a moderately tortuous and non-calcified lesion located in the right radial artery.A 145 cm ht versacore guide wire was inserted into the right arm of the patient, and after gaining radial access, the wire advanced to the aortic arch to take images.An unspecified balloon catheter that was advanced over the guide wire was removed and another unspecified catheter was inserted.Resistance met with the guide wire and the balloon catheter could not advance and it was removed, but the guide wire could not move forward or retract.Fluoroscopy showed the guide wire looked stretched.The guide wire remained embedded in the vessel while a femoral approach was used to complete the rest of the procedure.The patient was then transferred to the operating room for a surgical cut down.An incision was made in the patient's arm, and a decision was made to break the wire to remove 8.7 cm of the wire from the artery.The patient was then sent to surgical pathology for another surgical cut down, and the remainder of the wire was removed.The patient was discharged the following day.No additional information was provided.
Event or Problem Description
Medsun mandatory and voluntary report# (b)(4) received on 05/01/2018.
Additional Manufacturer Narrative
(b)(4).

• Brand Name: HI-TORQUE VERSACORE MODIFIED J GUIDE WIRE SYSTEM
• Common Device Name: GUIDE WIRE
• Manufacturer (Section D): AV-TEMECULA-CT; abbott vascular; 26531 ynez road; temecula CA 92591 4628
• MDR Report Key: 7492679
• Report Number: 2024168-2018-03365
• Device Sequence Number: 1705025
• Product Code: DQX
• UDI-Device Identifier: 08717648124150
• UDI-Public: 08717648124150
• Combination Product (Y/N): N
• Initial Reporter State: IL
• Initial Reporter Country: US
• PMA/510(K) Number: K083706
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Health Professional
• Remedial Action: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 05/08/2018

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: 01/31/2020
• Device Catalogue Number: 1012068-01
• Device Lot Number: 8020861
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 04/27/2018
• Initial Date Received by Manufacturer: 04/16/2018
• Supplement Date Received by Manufacturer: 05/07/2018
• Initial Report FDA Received Date: 05/07/2018
• Supplement Report FDA Received Date: 05/08/2018
• 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: Hospitalization; Required Intervention
• Patient Age: 62 YR
• Patient Weight: 98