MAUDE Adverse Event Report: AV-TEMECULA-CT ACS HI-TORQUE EXTRA SPORT GUIDE WIRE WITH MICROGLIDE COATING

Catalog Number	22235MS
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	10/14/2016
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.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 reported 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 at the end of the procedure in the anterior tibial artery, the tip of the sport guide wire was noted to have separated.The tip was embedded in a collateral vessel, but it did not impact blood flow.Tip embolization was not a concern as the tip was noted to be stable in the vessel.No additional intervention was performed for the tip detachment.The patient did not report symptoms related to this tip separation.No additional information was provided.

• Brand Name: ACS HI-TORQUE EXTRA SPORT GUIDE WIRE WITH MICROGLIDE COATING
• Common Device Name: GUIDE WIRE
• Manufacturer (Section D): AV-TEMECULA-CT; abbott vascular; 26531 ynez road; temecula CA 92591 4628
• MDR Report Key: 6077842
• Report Number: 2024168-2016-07576
• Device Sequence Number: 10912297
• Product Code: DQX
• UDI-Device Identifier: 08717648079603
• UDI-Public: (01)08717648079603(17)170228(10)5031061
• Combination Product (Y/N): N
• Initial Reporter State: PA
• 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): 11/03/2016

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: 02/28/2017
• Device Catalogue Number: 22235MS
• Device Lot Number: 5031061
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/18/2016
• Initial Report FDA Received Date: 11/03/2016
• 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: VOLCANO INTRAVASCULAR ULTRASOUND
• Outcome Attributed to Adverse Event: Other