MAUDE Adverse Event Report: AV-TEMECULA-CT HI-TORQUE COMMAND 14 GUIDE WIRE

Catalog Number	2078174
Medical Device Problem Codes	Failure to Advance (2524); Difficult to Advance (2920); Material Split, Cut or Torn (4008)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	02/25/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).Internal file number -(b)(4): during processing of this complaint, attempts were made to obtain complete event, patient and device information.The device was returned for analysis with the polymer of the tip torn.The reported difficult to position was unable to be confirmed.The reported failure to advance the device was unable to be replicated in a testing environment as it was 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 incidents from this lot.In this case, the investigation determined the reported difficulties appear to be related to circumstances of the procedure.Interaction/manipulation of the device resulted in the noted torn and wrinkled polymer coating.There is no indication of a product quality issue with respect to manufacture, design or labeling of the device.
Event or Problem Description
It was reported that during a procedure of the non-tortuous, eccentric, mid anterior tibial artery, the command wire transition could not advance pass a certain section of the non-abbott guide catheter.Each device was removed separately from the anatomy without reported issue.A different non-abbott guide wire was attempted with the same outcome.There was no reported adverse patient effect.There was no reported clinically significant delay in the procedure.No additional information was provided.*returned device analysis revealed the polymer coating on the tip was torn.

• Brand Name: HI-TORQUE COMMAND 14 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: 8500696
• Report Number: 2024168-2019-02789
• Device Sequence Number: 11435379
• Product Code: DQX
• UDI-Device Identifier: 08717648176678
• UDI-Public: 08717648176678
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• 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): 04/10/2019

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: 06/30/2020
• Device Catalogue Number: 2078174
• Device Lot Number: 8072371
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/14/2019
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/26/2019
• Initial Report FDA Received Date: 04/10/2019
• 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: GUIDE CATH: CXI 0.14 90CM
• Patient Age: 71 YR
• Patient Weight: 36