MAUDE Adverse Event Report: ABBOTT VASCULAR HI TORQUE SPORTACORE GUIDE WIRE

Catalog Number	1005203
Medical Device Problem Code	Material Separation (1562)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	12/11/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Exemption number e2019001.The device will not be returned for evaluation, the device was reportedly discarded.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 this was a procedure to treat a lesion with heavy calcification and no tortuosity in the iliac artery.A non-abbott balloon catheter was advanced over the sparta core guide wire to the target lesion without resistance.After pre-dilatation, the balloon catheter was removed, and it was noted that the guide wire separated 3 to 5 cm from the tip.The separated portion was retrieved from the anatomy via a snare device.There was no resistance noted during removal of the balloon catheter.The procedure was completed using another new guide wire and a stent implanted successfully.No additional information was provided.
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.Product performance engineering reviewed the incident information; however, the product was not returned to abbott vascular for analysis.The lot history record and similar incident query for this product/lot was not reviewed since the lot number was not reported.There was no damage noted to the guide wire during the inspection prior to use which suggests a product quality issue did not contribute to the reported difficulties.The investigation determined the reported tip separation appears to be related to operation circumstances of the procedure.It is likely that during advancement and/or pre-dilatation of the anatomy, the guide wire inadvertently kinked against the anatomy or other devices used resulting in the reported separation.There is no indication of a product quality issue with respect to the design, manufacture, or labeling of the device.

• Brand Name: HI TORQUE SPORTACORE GUIDE WIRE
• Common Device Name: GUIDE WIRE
• Manufacturer (Section D): ABBOTT VASCULAR; 26531 ynez rd.; temecula CA 92591 4628
• MDR Report Key: 9526118
• Report Number: 2024168-2019-15032
• Device Sequence Number: 13567907
• Product Code: DQX
• UDI-Device Identifier: 08717648014031
• UDI-Public: 08717648014031
• Combination Product (Y/N): N
• Initial Reporter State: TX
• 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,Followup
• Report Date (Section B): 01/14/2020

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 Catalogue Number: 1005203
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 12/11/2019
• Supplement Date Received by Manufacturer: 01/09/2020
• Initial Report FDA Received Date: 12/27/2019
• Supplement Report FDA Received Date: 01/14/2020
• 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