MAUDE Adverse Event Report: AV-TEMECULA-CT HI-TORQUE BALANCE MIDDLEWEIGHT UNIVERSAL GUIDE WIRE

Catalog Number	1009661
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	02/11/2017
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).Evaluation summary: the device was returned for analysis.Visual inspections were performed on the returned device.The separation was confirmed.It was reported the guide wire was used in the tibial artery.It should be noted the hi torque guide wires instructions for use states: all hi-torque guide wires are intended to facilitate the placement of balloon dilatation catheters during percutaneous transluminal coronary angioplasty (ptca) and percutaneous transluminal angioplasty (pta).The investigation determined the separation to be related to circumstances of the procedure.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.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 the procedure was to treat a lesion located in the distal tibial artery that was mildly tortuous.The hi-torque balance middleweight (bmw) guide wire was being used with a non-abbott micro-catheter.When the bmw was being removed from the anatomy, the core of the wire separated in the vessel.Two attempts were made to snare the separated portion of wire but were both unsuccessful.However, when the non-abbott micro-catheter was being removed, the separated guide wire came out of the anatomy with the catheter.Nothing was left in the patient.Although there was a 25 minute delay in the procedure, it was not clinically significant.There were no adverse patient effects.No additional information was reported.

• Brand Name: HI-TORQUE BALANCE MIDDLEWEIGHT UNIVERSAL 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: 6415610
• Report Number: 2024168-2017-02301
• Device Sequence Number: 18967722
• Product Code: DQX
• UDI-Device Identifier: 08717648014345
• UDI-Public: (01)08717648014345(17)180831(10)6091271
• Combination Product (Y/N): N
• Initial Reporter State: MD
• 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): 03/17/2017

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: 08/31/2018
• Device Catalogue Number: 1009661
• Device Lot Number: 6091271
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/03/2017
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/28/2017
• Initial Report FDA Received Date: 03/17/2017
• 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: GUIDE CATHETER: FINECROSS
• Outcome Attributed to Adverse Event: Required Intervention