MAUDE Adverse Event Report: ABBOTT VASCULAR HI TORQUE SUPRA CORE 35; GUIDE WIRE

Catalog Number	1002703-01
Medical Device Problem Codes	Peeled/Delaminated (1454); Difficult to Advance (2920); Material Deformation (2976)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	07/05/2019
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.A visual and dimensional inspections were performed and the reported deformed and overlapped coils were confirmed.The reported difficult to advance the guide wire through an introducer sheath was unable to be confirmed due to the condition of the wire.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.There was no damage noted to the guide wire during the inspection prior to use which suggests a product quality issue with respect to manufacture, design or labeling did not contribute to the reported difficulties.The investigation determines the reported difficulty to advance through the introducer sheath and deformed and deformed/overlapped coils appear to be related to operational circumstances of the procedure.It is likely that manipulation and/or inadvertent mishandling of the guide wire during advancement through the introducer sheath resulted in the coil damage at the proximal end of the wire resulting in the reported difficulty to advance through the introducer sheath.The noted damaged to the guide wire likely occurred during the handling and cutting of the guide wire not to lose vessel access.There is no indication of a product quality issue with respect to manufacture, design or labeling.
Event or Problem Description
It was reported that the procedure was performed to treat a lesion in the superficial femoral artery.A hi-torque supra core 35 guide wire was advanced without resistance; however, the coils bunched up which resulted in an increase in diameter at the proximal end outside the patient anatomy.The physician didn¿t want to lose vessel access and bunching of the coils did not allow a 6f sheath to advance over the guide wire; therefore, the guide wire was cut to advance the 6f sheath.The 6f sheath was able to be successfully used.Access was maintained in order to use a closure device, but the case was abandoned post closure.There were no adverse patient effects and no clinically significant delay in the procedure.Subsequently, the return device analysis identified that the teflon on the proximal ribbon coil at the separation was scratched and peeling.No additional information was provided.

• Brand Name: HI TORQUE SUPRA CORE 35
• Common Device Name: GUIDE WIRE
• Manufacturer (Section D): ABBOTT VASCULAR; 26531 ynez rd.; temecula CA 92591 4628
• MDR Report Key: 8963053
• Report Number: 2024168-2019-11455
• Device Sequence Number: 2860108
• Product Code: DQX
• UDI-Device Identifier: 08717648032998
• UDI-Public: 08717648032998
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• 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: Physician
• Type of Report: Initial
• Report Date (Section B): 09/04/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 02/28/2021
• Device Catalogue Number: 1002703-01
• Device Lot Number: 9032561
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/25/2019
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 08/06/2019
• Initial Report FDA Received Date: 09/04/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: 6F SHEATH