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

Catalog Number	22225M
Medical Device Problem Codes	Difficult to Remove (1528); Material Separation (1562)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	03/04/2019
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 the reported difficulties appear to be related to circumstances of the procedure as it is likely that during removal resistance was met with the guide catheter, the other guide wire and the ultra stent delivery system that was loaded on the other guide wire resulting in the reported difficulty to remove.Manipulation of the device ultimately resulted in the reported tip detachment.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 s'port guide wire was advanced to the moderately calcified proximal right coronary artery.When the s'port guide wire was being removed from the anatomy, resistance was met with the guide catheter, the other guide wire and the ultra stent delivery system that was loaded on the other guide wire.The tip of the s'port separated, but remained inside the guide catheter.When the guide catheter was removed, the tip of the s'port was removed with the guide catheter.There were no adverse patient effects and no clinically significant delay in the procedure.

• 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: 8432820
• Report Number: 2024168-2019-02112
• Device Sequence Number: 1103919
• Product Code: DQX
• UDI-Device Identifier: 08717648079573
• UDI-Public: 08717648079573
• Combination Product (Y/N): N
• Initial Reporter State: AZ
• 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: Physician
• Remedial Action: Other
• Type of Report: Initial
• Report Date (Section B): 03/19/2019

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: 22225M
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/04/2019
• Initial Report FDA Received Date: 03/19/2019
• 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: ULTRA STENT DELIVERY SYSTEM