MAUDE Adverse Event Report: ABBOTT VASCULAR HI-TORQUE VERSACORE GUIDE WIRE

Catalog Number	1012068-08
Medical Device Problem Code	Material Separation (1562)
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
G9: exemption number e2019001-permits numbering sequence to begin with 10000, to avoid duplication of report numbers due to process transition.There may be gaps in numbering for reports submitted during the transition period.The device is expected to be returned for investigation.It has not yet been received.A follow-up report will be submitted with all additional relevant information.The other additional hi-torque versacore guide wire referenced in b5 is being filed under a separate medwatch report number.Na.
Event or Problem Description
It was reported that two hi-torque versacore guide wires were found in a package left on a table.On the package, it was written that the guide wires had a fracture on each wire.There were no reported adverse patient effects and no reported clinically significant delay in the procedure.No additional information was provided.
Additional Manufacturer Narrative
Exemption number e2019001-permits numbering sequence to begin with 10000, to avoid duplication of report numbers due to process transition.There may be gaps in numbering for reports submitted during the transition period.A visual inspection was performed on the returned guide wire, and the reported separation was unable to be confirmed.There no visible separation or breaks on the guide wire.A review of the lot history record identified no manufacturing nonconformities issued to the reported lot that would have contributed to this event.Based on the review of similar incident(s) there is no indication of a lot specific product quality issue.The investigation was unable to determine a conclusive cause for the reported separation.Guide wire separations may occur when the wire is subjected to tensile or torsional loads beyond its design limits causing the guide wire to detach.There is no indication of a product quality issue with respect to manufacture, design or labeling.

• Brand Name: HI-TORQUE VERSACORE GUIDE WIRE
• Common Device Name: GUIDE WIRE
• Manufacturer (Section D): ABBOTT VASCULAR; 26531 ynez rd.; temecula CA 92591 4628
• MDR Report Key: 8842554
• Report Number: 2024168-2019-10448
• Device Sequence Number: 259753
• Product Code: DQX
• UDI-Device Identifier: 08717648124228
• UDI-Public: 08717648124228
• Combination Product (Y/N): N
• Initial Reporter State: OH
• Initial Reporter Country: US
• PMA/510(K) Number: K083706
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 10/01/2019

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: 08/31/2020
• Device Catalogue Number: 1012068-08
• Device Lot Number: 8090661
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/21/2019
• Initial Date Received by Manufacturer: 07/08/2019
• Supplement Date Received by Manufacturer: 09/12/2019
• Initial Report FDA Received Date: 07/30/2019
• Supplement Report FDA Received Date: 10/01/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1