MAUDE Adverse Event Report: AV-TEMECULA-CT ACS HI-TORQUE IRON MAN GUIDE WIRE

Catalog Number	1001311S
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	08/25/2016
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 reported from this lot.The investigation determined the difficulties appear to be related to circumstances of the procedure.Based on the information reviewed, there is no indication of a product quality issue with respect to the design, manufacture, or labeling of the device.
Event or Problem Description
It was reported that during the procedure to treat a moderately calcified lesion in the non-tortuous peroneal artery, a 014 iron man guide wire was advanced past the target lesion without resistance.A non-abbott atherectomy device was advanced over the iron man without resistance and atherectomy was performed without issue.However, when the atherectomy device reached the tip of the iron man, it caused the tip to bunch then separate in a small peroneal side-branch vessel.The atherectomy device was then retracted over the iron man without resistance, followed by withdrawal of the iron man guide wire without difficulty.An attempt was made to snare the separated iron man tip, but the tip was too far distal to be reached.As the physician felt that leaving the tip would not cause adverse patient sequelae, the tip was left in small side-branch vessel.The atherectomy procedure was considered completed.There were no adverse patient sequelae and no occurrence of a clinically significant delay.No additional information has been provided.

• Brand Name: ACS HI-TORQUE IRON MAN 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: 5943846
• Report Number: 2024168-2016-06027
• Device Sequence Number: 10876140
• Product Code: DQX
• UDI-Device Identifier: 08717648013652
• UDI-Public: (01)08717648013652(17)180531(10)6060661
• Combination Product (Y/N): N
• Initial Reporter State: TX
• 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: Health Professional
• Remedial Action: Other
• Type of Report: Initial
• Report Date (Section B): 09/12/2016

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: 05/31/2018
• Device Catalogue Number: 1001311S
• Device Lot Number: 6060661
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/25/2016
• Initial Report FDA Received Date: 09/12/2016
• 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: ATHERECTOMY: VOLCANO PHOENIX
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 81 YR