MAUDE Adverse Event Report: AV-TEMECULA-CT ACS HI-TORQUE BALANCE MIDDLEWEIGHT GUIDE WIRE WITH HYDROCOAT HYDROPHILIC COATING

Catalog Number	1001782S-HC
Health Effect - Clinical Code	Perforation (2001)
Date of Event	10/21/2016
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.(b)(4).The device was returned for analysis.Visual and dimensional inspections were performed on the returned device.The separation was confirmed.The difficulty removing the device could not 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 similar incidents from this lot.The investigation was unable to determine a conclusive cause for the reported perforation; however the reported difficulty removing the device, separations, and treatments appear to be related to circumstances of the procedure.Additionally, it should be noted the hi torque guide wires instructions for use (ifu) states: if resistance is observed at any time, determine the cause under fluoroscopy and take remedial action as needed.Do not push, auger, withdraw, or torque a guide wire that meets resistance.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 lesion in the right common iliac artery, a 014 balance middleweight (bmw) hydro 3cm guide wire was advanced via right groin access past the lesion without issue.A non-abbott intravascular ultrasound (ivus) catheter was advanced over the bmw to the lesion without issue and images were obtained.When retracting the ivus back over the bmw, resistance was felt.Force was applied against resistance to completely retract the ivus off of the bmw.It was then noted that the bmw guide wire had separated in patient anatomy; while the core was outside of the anatomy, three tip pieces were found inside of the iliac vessel and a perforation was also noted; the exact cause of the perforation is reportedly unknown.Another bmw guide wire was advanced without issue then balloon tamponade of the perforation was attempted with an unspecified balloon, but the perforation did not seal.A non-abbott stent graft was then deployed and successfully sealed the perforation.Two tip pieces were able to be snared successfully.The final tip piece (3rd ) was successfully retrieved via a small cut down of the iliac artery and the lesion was successfully treated using the replacement bmw.While this issue caused delay, it did not result in a health impact to the patient.There were no adverse patient sequelae.The patient was discharged the same day in good condition.No additional information was provided.

• Brand Name: ACS HI-TORQUE BALANCE MIDDLEWEIGHT GUIDE WIRE WITH HYDROCOAT HYDROPHILIC COATING
• Common Device Name: GUIDE WIRE
• Manufacturer (Section D): AV-TEMECULA-CT; abbott vascular; 26531 ynez road; temecula CA 92591 4628
• MDR Report Key: 6111640
• Report Number: 2024168-2016-08063
• Device Sequence Number: 18923363
• Product Code: DQX
• UDI-Device Identifier: 08717648025990
• UDI-Public: (01)08717648025990(17)180331(10)6042671
• Combination Product (Y/N): N
• Initial Reporter State: NC
• Initial Reporter Country: US
• PMA/510(K) Number: K013833
• 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): 11/17/2016

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: 03/31/2018
• Device Catalogue Number: 1001782S-HC
• Device Lot Number: 6042671
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/28/2016
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/24/2016
• Initial Report FDA Received Date: 11/17/2016
• 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: OTHER: VOLCANO INTRAVASCULAR ULTRASOUND CATHETER
• Outcome Attributed to Adverse Event: Required Intervention