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

Model Number	1005203
Medical Device Problem Codes	Break (1069); Difficult to Insert (1316); Stretched (1601)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	08/17/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
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.The product risk assessment identifies this as a foreseeable event.The investigation was unable to determine a cause for the reported stretched coil, break and difficult to insert events.It may be possible that during insertion of the wire into the bdc the coils were stretched, possibly due to a break, and that created the resistance making it difficult to insert.This could not be confirmed because the guide wire was not returned.There is no indication of a product quality issue with respect to the design, manufacture, or labeling of the device.
Event or Problem Description
It was reported that after inserting into the balloon dilatation catheter (bdc) with resistance noted, the tip of the spartacore guide wire was shredded/coils were exposed [possible breakage] and unable to be used.The guide wire was immediately removed.It was confirmed that nothing remained in the patient.A new guide wire was used to complete the procedure.There were no adverse patient effects and there was no reported clinically significant delay in the procedure.No additional information was provided.

• 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: 10490567
• Report Number: 2024168-2020-07370
• Device Sequence Number: 11434808
• Product Code: DQX
• UDI-Device Identifier: 08717648014031
• UDI-Public: 08717648014031
• Combination Product (Y/N): N
• Initial Reporter State: SC
• Initial Reporter Country: US
• PMA/510(K) Number: K963702
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 09/03/2020

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: 11/30/2021
• Device Model Number: 1005203
• Device Catalogue Number: 1005203
• Device Lot Number: 9121261
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 08/17/2020
• Initial Report FDA Received Date: 09/03/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1