MAUDE Adverse Event Report: ABBOTT VASCULAR HT WINN GUIDE WIRE

Catalog Number	1012475
Medical Device Problem Code	Improper or Incorrect Procedure or Method (2017)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	09/19/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Exemption number e2019001.The device was not returned for analysis.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.It should be noted that the hi-torque guide wires for ptca, pta, and stents instructions for use states: carefully read all instructions prior to use.Observe all warnings and precautions noted throughout these instructions.Failure to do so may result in complications.The investigation determined the reported difficulties appear to be related to use error as the device was used past the expiration date.There is no indication of a product quality issue with respect to manufacture, design or labeling.(b)(4).
Event or Problem Description
It was reported that a hi-torque winn 200t 300cm guide wire was used on (b)(6) 2019, and after the procedure, it was noted that the expiration date was 05/31/2019.There were no adverse patient effects and no clinically significant delay in the procedure.No additional information was provided.

• Brand Name: HT WINN GUIDE WIRE
• Common Device Name: GUIDE WIRE
• Manufacturer (Section D): ABBOTT VASCULAR; 26531 ynez rd.; temecula CA 92591 4628
• MDR Report Key: 9458892
• Report Number: 2024168-2019-14438
• Device Sequence Number: 11539140
• Product Code: DQX
• UDI-Device Identifier: 08717648156908
• UDI-Public: 08717648156908
• Combination Product (Y/N): N
• Initial Reporter Country: MY
• PMA/510(K) Number: K101648
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 12/12/2019

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 Expiration Date: 05/31/2019
• Device Catalogue Number: 1012475
• Device Lot Number: 7063071
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 11/20/2019
• Initial Report FDA Received Date: 12/12/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1