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

Catalog Number	1011880
Medical Device Problem Codes	Material Separation (1562); Difficult to Advance (2920)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	03/08/2019
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 returned for analysis.The reported detachment was able to be confirmed.The reported difficult to position was unable to be replicated in a testing environment due to the condition of the returned device.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.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 mildly tortuous subclavian artery.Intravascular ultrasound (ivus) was being performed with a 014 hi-torque balance middle weight guide wire (gw).As the gw was advanced resistance was felt with the ivus catheter when it was observed that the gw core broke in two pieces.The separated portion was successfully snared.Nothing remained in the anatomy.There was no adverse patient sequela reported.No additional information was provided.

• Brand Name: HI-TORQUE BALANCE MIDDLEWEIGHT ELITE 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: 8454005
• Report Number: 2024168-2019-02334
• Device Sequence Number: 16900672
• Product Code: DQX
• UDI-Device Identifier: 08717648144783
• UDI-Public: 08717648144783
• Combination Product (Y/N): N
• Initial Reporter State: NC
• Initial Reporter Country: US
• PMA/510(K) Number: K103101
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Remedial Action: Other
• Type of Report: Initial
• Report Date (Section B): 03/26/2019

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: 12/31/2020
• Device Catalogue Number: 1011880
• Device Lot Number: 9010261
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/15/2019
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/08/2019
• Initial Report FDA Received Date: 03/26/2019
• 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: Required Intervention