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

Model Number	1005202
Medical Device Problem Codes	Break (1069); Peeled/Delaminated (1454); Stretched (1601)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	09/07/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device is expected to be returned for analysis.It has not yet been received.A follow-up report will be submitted with all additional relevant information.
Event or Problem Description
It was reported that the coating of the hi-torque spartacore 14 guide wire came off.A photo received from the account to show the malfunction confirms the coils were stretched and possibly unraveled.There were no reported adverse patient effects.No additional information was provided.
Additional Manufacturer Narrative
A visual inspection was performed on the returned guide wire and the reported break and stretched coils was confirmed.The reported peeling was unable 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 similar incidents reported from this lot.The investigation determined the reported core break, stretched coils and peeling appear to be related to operation circumstances of the procedure.Based on the reported information, sem analysis, and returned analysis, it is likely that during advancement and/or the procedure the guide wire tip became kinked against the anatomy or other devices used.Manipulation, inadvertent mishandling or ductile overload ultimately resulted in the core break, coils damages and likely the appearance of peeling.Additionally, it is likely that the noted deep scratches on the guide wire teflon and core likely occurred during retraction through the torque device used in the procedure.The noted bends on the guide wire likely occurred during packing for return analysis.Corrosion was noted on the guide wire and likely a result of exposure to the elements during transit back to abbott vascular for analysis.There is no indication of a product quality issue with respect to the design, manufacture, or labeling of the device.Na.

• Brand Name: HI-TORQUE SPARTACORE GUIDE WIRE
• Common Device Name: GUIDE WIRE
• Manufacturer (Section D): ABBOTT VASCULAR; 26531 ynez rd.; temecula CA 92591 4628
• MDR Report Key: 10617730
• Report Number: 2024168-2020-08204
• Device Sequence Number: 3735211
• Product Code: DQX
• UDI-Device Identifier: 08717648014024
• UDI-Public: 08717648014024
• Combination Product (Y/N): N
• Initial Reporter Country: NZ
• PMA/510(K) Number: K963702
• 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,Followup
• Report Date (Section B): 12/14/2020

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: 02/28/2022
• Device Model Number: 1005202
• Device Catalogue Number: 1005202
• Device Lot Number: 0031861
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/26/2020
• Initial Date Received by Manufacturer: 09/07/2020
• Supplement Date Received by Manufacturer: 12/09/2020
• Initial Report FDA Received Date: 10/01/2020
• Supplement Report FDA Received Date: 12/15/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1