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

Catalog Number	1011883
Medical Device Problem Codes	Difficult to Remove (1528); Difficult to Advance (2920)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	12/23/2018
Type of Reportable Event	Malfunction
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 and complaint history of the reported lot could not be conducted because the lot number was not provided.The investigation determined a conclusive cause for the reported difficulties cannot be determined.There is no indication of a product quality issue with respect to manufacture, design or labeling.The xience prox referenced is being filed under a separate medwatch report.
Event or Problem Description
It was reported that the procedure was to treat a mildly tortuous and mildly calcified unspecified coronary artery.A 3.0 x 28 mm xience prox stent delivery system (sds) and an unspecified balance middleweight (bmw) guide wire were used.However, during advancement, the sds became stuck with the guide wire and was not able to advance towards the lesion.Therefore, both devices were removed as a single unit, and there was no damage noted to the guide wire.Another unspecified device was then used with a different unspecified guide wire to successfully complete the procedure.There were no adverse patient effects and no clinically significant delay in the procedure.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: 8302561
• Report Number: 2024168-2019-00804
• Device Sequence Number: 986426
• Product Code: DQX
• UDI-Device Identifier: 08717648144844
• UDI-Public: 08717648144844
• Combination Product (Y/N): N
• Initial Reporter Country: IT
• PMA/510(K) Number: K103101
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other Health Care Professional
• Remedial Action: Other
• Type of Report: Initial
• Report Date (Section B): 02/04/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Catalogue Number: 1011883
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/11/2019
• Initial Report FDA Received Date: 02/04/2019
• 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: STENT: XIENCE PROX 3.0X28