MAUDE Adverse Event Report: AV-TEMECULA-CT HI-TORQUE PROGRESS 80 GUIDE WIRE

Catalog Number	1011838
Health Effect - Clinical Code	Vessel Or Plaque, Device Embedded In (1204)
Date of Event	05/23/2018
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.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.Interaction with the totally occluded anatomy and/or manipulation of the device resulted in the reported tip 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 to treat a chronic total occlusion of the distal right coronary artery.A 190 cm ht progress 80 guide wire was used; however, the device failed to cross the lesion due to the anatomy.Additionally, the tip of the device was noted to be separated and was stuck in the patient anatomy and was not free-floating.There was no adverse patient sequela reported.The patient was discharged from the hospital and is stable.No additional information was provided.

• Brand Name: HI-TORQUE PROGRESS 80 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: 7603830
• Report Number: 2024168-2018-04491
• Device Sequence Number: 19181585
• Product Code: DQX
• UDI-Device Identifier: 08717648144103
• UDI-Public: 08717648144103
• Combination Product (Y/N): N
• Initial Reporter Country: BR
• PMA/510(K) Number: K091825
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,distri
• Initial Reporter Occupation: Health Professional
• Remedial Action: Other
• Type of Report: Initial
• Report Date (Section B): 06/14/2018

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: 1011838
• Device Lot Number: 7052571
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/24/2018
• Initial Report FDA Received Date: 06/14/2018
• 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: Other