MAUDE Adverse Event Report: AV-TEMECULA-CT HT VERSATURN GUIDE WIRE

Catalog Number	1013317J
Medical Device Problem Codes	Entrapment of Device (1212); Material Separation (1562); Improper or Incorrect Procedure or Method (2017)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	07/20/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4): during processing of this complaint, attempts were made to obtain complete event, patient and device information.(b)(4).The device was not returned for analysis.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 from this lot.It should be noted that the hi-torque guide wire instructions for use states: do not: push, auger, withdraw or torque a guide wire that meets resistance.This may result in vessel trauma, guide wire damage, guide wire tip separation, or stent damage.If resistance is observed at any time, determine the cause under fluoroscopy and take remedial action as needed.Although it was noted that resistance was noted during retraction of the guide wire, this was due to the guide wire being stuck; therefore, the force applied seems to be a reasonable clinical response to the difficulties.The investigation determined the reported difficulties appear to be related to circumstances of the procedure as it is likely that during removal the guide wire got caught on the non-abbott stent resulting in the reported entrapment.Manipulation of the device with force ultimately resulted in the reported detachment.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 procedure was performed to treat a de novo lesion, below the bifurcation of the marginal and left anterior descending coronary arteries.On removal of a high torque versaturn guidewire, resistance with a non-abbott stent was felt.The guidewire was removed with force and a separation occurred at the distal radiopaque portion of the wire.The tip of the guidewire remained caught by the stent.Retrieval of the separated portion of the guidewire with an additional unspecified wire was attempted but failed.The separated portion of the guidewire remained in the anatomy.The patient condition was reported to be good.There was no clinically significant delay in the procedure.No additional information was provided.

• Brand Name: HT VERSATURN GUIDE WIRE
• Common Device Name: GUIDE WIRE
• Manufacturer (Section D): AV-TEMECULA-CT; abbott vascular; 26531 ynez road; temecula CA 92591 4628
• MDR Report Key: 7735813
• Report Number: 2024168-2018-05892
• Device Sequence Number: 806051
• Product Code: DQX
• UDI-Device Identifier: 08717648198472
• UDI-Public: 08717648198472
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• PMA/510(K) Number: K103101
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Remedial Action: Other
• Type of Report: Initial
• Report Date (Section B): 07/31/2018

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: 11/30/2019
• Device Catalogue Number: 1013317J
• Device Lot Number: 7120461
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/20/2018
• Initial Report FDA Received Date: 07/31/2018
• 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: STENT: ORSIRO 2.5X40MM
• Outcome Attributed to Adverse Event: Required Intervention