MAUDE Adverse Event Report: AV-TEMECULA-CT 014 HT WINN GUIDE WIRE

Catalog Number	1012467
Health Effect - Clinical Code	Vessel Or Plaque, Device Embedded In (1204)
Date of Event	02/07/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(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 the hi-torque guide wires for ptca, pta, and stents instructions for use states: do not: allow the guide wire tip to remain in a prolapsed condition.Failure to do so may result in vessel trauma, guide wire damage, guide wire tip separation, or stent damage.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 heavily calcified de novo, chronic total occlusion of the anterior tibial artery.A 300 cm winn guide wire was used; however, the tip of the guide wire prolapsed due to the anatomy when the guide wire was being torqued.Then the guide wire became stuck during advancement due to the anatomy, causing the tip to become separated.The tip was embedded in healthy tissue and there was a failed attempt to snare it.The patient was in stable condition and the blood flow in the leg was not affected by the embedded tip of the guide wire.Therefore, the separated guide wire tip was left in the anatomy, and the device was removed independently through an unspecified introducer sheath to complete the procedure.There was no adverse patient sequela reported.No additional information was provided.

• Brand Name: 014 HT WINN 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: 7284307
• Report Number: 2024168-2018-01258
• Device Sequence Number: 1993981
• Product Code: DQX
• UDI-Device Identifier: 08717648156823
• UDI-Public: 08717648156823
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: K091825
• 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
• Report Date (Section B): 02/20/2018

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: 04/30/2019
• Device Catalogue Number: 1012467
• Device Lot Number: 7051771
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/07/2018
• Initial Report FDA Received Date: 02/20/2018
• 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