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

Catalog Number	1005205
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	01/28/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).The device was received.Investigation is not yet complete.A follow up report will be submitted with all additional relevant information.
Event or Problem Description
It was reported that the procedure was to treat an occlusive lesion located in the distal peroneal artery.During dilatation of the right leg artery, the distal tip of the high-torque spartacore peripheral guide wire separated in the atheroma plaque during removal.The tip remains located in the right peroneal artery.An attempt was made to remove the tip but it could not be extracted from the atheroma plaque and remains in the patient.No additional information was provided.
Additional Manufacturer Narrative
(b)(4).The device was returned for analysis.The reported detachment was able to be confirmed.The reported difficulty to remove was unable to be replicated in a testing environment due to the condition of the returned device.The reported physical resistance was unable to be replicated in a testing environment as it was based on operational circumstances.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.There is no indication of a product quality issue with respect to manufacture, design or labeling.
Event or Problem Description
Subsequent to the previously filed medwatch report, there was resistance during advancement with the anatomy as the peroneal artery had major calcification.There was also resistance during removal of the device as well.The separated guide wire was attempted to be removed with a command guide wire and an over the wire (otw) catheter, however it was unsuccessful, thus the distal part is fixed in the atheroma plaque against the arterial wall.There was no clinically significant delay and the final patient outcome is good.

• Brand Name: HI-TORQUE SPARTACORE 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: 7308330
• Report Number: 2024168-2018-01503
• Device Sequence Number: 19051848
• Product Code: DQX
• UDI-Device Identifier: 08717648014055
• UDI-Public: 08717648014055
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• PMA/510(K) Number: K980119
• 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,Followup
• Report Date (Section B): 03/19/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 05/31/2019
• Device Catalogue Number: 1005205
• Device Lot Number: 7061461
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 02/22/2018
• Initial Date Received by Manufacturer: 02/06/2018
• Supplement Date Received by Manufacturer: 03/12/2018
• Initial Report FDA Received Date: 03/01/2018
• Supplement Report FDA Received Date: 03/19/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 84 YR