MAUDE Adverse Event Report: AV-TEMECULA-CT HI-TORQUE FLOPPY II GUIDE WIRE

Catalog Number	22359MS
Medical Device Problem Codes	Difficult to Remove (1528); Material Separation (1562); Improper or Incorrect Procedure or Method (2017); Difficult to Advance (2920)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	07/05/2018
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.The investigation determined the reported difficulties appear to be related to circumstances of the procedure and as the guide wire was advanced and resistance was met with the heavily tortuosity, moderately calcified anatomy resulting in the reported physical resistance.During removal, resistance was met again with the anatomy resulting in the reported difficulty to remove.Interaction with the anatomy and/or manipulation of the device using force resulted in the reported tip detachment.It should be noted that the hi-torque guide wires instructions for use (ifu) states: do not push, auger, withdraw or torque a guide wire that meets resistance.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 to treat a lesion in the heavily tortuosity, moderately calcified ramous coronary artery.Resistance was felt with the anatomy during advancement of the floppy ii exchange guide wire.During removal, resistance was felt again with the anatomy.Force was used during removal and the guide wire tip separated in the anatomy.A stent was implanted embedding the guide wire tip against the vessel wall.There was no clinically significant delay during the procedure.No further information was provided.

• Brand Name: HI-TORQUE FLOPPY II 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: 7719874
• Report Number: 2024168-2018-05757
• Device Sequence Number: 903918
• Product Code: DQX
• UDI-Device Identifier: 08717648080319
• UDI-Public: 08717648080319
• Combination Product (Y/N): N
• Initial Reporter State: AL
• Initial Reporter Country: US
• PMA/510(K) Number: K060449
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Remedial Action: Other
• Type of Report: Initial
• Report Date (Section B): 07/25/2018

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: 03/31/2020
• Device Catalogue Number: 22359MS
• Device Lot Number: 8040261
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/05/2018
• Initial Report FDA Received Date: 07/25/2018
• 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: Required Intervention