MAUDE Adverse Event Report: AV-TEMECULA-CT HI-TORQUE FLOPPY II GUIDE WIRE

Catalog Number	22339M-901
Health Effect - Clinical Code	No Patient Involvement (2645)
Date of Event	03/02/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).Evaluation summary: the device was returned for analysis with the shaping ribbon detached.The reported kink was able to be confirmed.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reported difficulties appear to be related to circumstances of the procedure as it is likely that the guide wire was withdrawn from the dispenser coil at an angle at the exit port of the dispenser coil causing the reported/noted damages (kinked/bent core, stretched coils, bent/detached shaping ribbon).There is no indication of a product quality issue with respect to manufacture, design or labeling.
Event or Problem Description
It was reported that before use, when the high-torque (ht) floppy ii guide wire was unpackaged, the guide wire tip was bent.The device was not used and there was no patient involvement.A new ht floppy ii guide wire was used from a different lot number to complete the procedure.There was no reported adverse patient effect.There was no reported clinically significant delay in the procedure.No additional information was provided.Device analysis revealed the shaping ribbon was detached.

• Brand Name: HI-TORQUE FLOPPY II 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: 7479602
• Report Number: 2024168-2018-03217
• Device Sequence Number: 1543166
• Product Code: DQX
• UDI-Device Identifier: 08717648080111
• UDI-Public: 08717648080111
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: K060449
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Health Professional
• Remedial Action: Other
• Type of Report: Initial
• Report Date (Section B): 05/02/2018

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 Expiration Date: 10/31/2019
• Device Catalogue Number: 22339M-901
• Device Lot Number: 7110261
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/12/2018
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/23/2018
• Initial Report FDA Received Date: 05/02/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1