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

Catalog Number	1010485-H
Medical Device Problem Code	Improper or Incorrect Procedure or Method (2017)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	09/07/2018
Type of Reportable Event	Malfunction
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.The reported use after expiration date issue was able to be confirmed.It should be noted that the hi-torque guide wires instructions for use, states: refer to the device label for any additional product-specific indications that may apply.A review of the labels attached to the electronic lot history record for this lot was conducted and all labels indicated an expiration date (use by date) of (b)(6) 2018.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.There is no indication of a product quality issue with respect to manufacture, design or labeling.The investigation determined the reported difficulties appear to be related to use error as the device was used past the expiration date.There is no indication of a product quality issue with respect to manufacture, design or labeling.The additional hi-torque guide wire referenced is filed under separate medwatch report.
Event or Problem Description
It was reported that during a peripheral procedure to treat a target lesion in the leg, two hi-torque pilot 200 guide wires were used.There was no reported device issue with either guide wire and no reported adverse patient effect.However, at some time, it was noted that the guide wires had been used after expiration date.No additional information was provided.

• Brand Name: HI-TORQUE PILOT 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: 7895841
• Report Number: 2024168-2018-07311
• Device Sequence Number: 16766274
• Product Code: DQX
• UDI-Device Identifier: 08717648073953
• UDI-Public: 08717648073953
• Combination Product (Y/N): N
• Initial Reporter State: CO
• 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): 09/20/2018

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: 01/31/2018
• Device Catalogue Number: 1010485-H
• Device Lot Number: 6022571
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/14/2018
• Initial Report FDA Received Date: 09/20/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 65 YR