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

Catalog Number	1002703-01
Medical Device Problem Codes	Flaked (1246); Product Quality Problem (1506); Difficult to Advance (2920)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	07/08/2019
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.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 during a procedure, a non-abbott 6f sheath was unable to be advanced over a hi torque supra core 35 guide wire due to a rough area on the core towards the tip of the wire.A new surpacore guide wire was used successfully to complete the procedure.There was no adverse patient effects and no clinically significant delay in the procedure.No additional information was provided.Returned goods analysis identified that there were three pieces of detached teflon coating noted on the proximal solder joint.
Additional Manufacturer Narrative
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.Visual, dimensional and functional inspections were performed and the reported difficulty to advance and irregular texture were confirmed.Additionally, three pieces of detached teflon coating were noted on the proximal solder joint and the coils were noted to be overlapping.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 determined the reported difficulty to advance through the introducer sheath and irregular texture 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 likely resulted in noted overlapped coils causing the irregular texture of feeling during advancement through the sheath.The noted damaged to the teflon coating likely occurred during retraction from the introducer sheath and/or from the torque device used in the procedure.There is no indication of a product quality issue with respect to manufacture, design or labeling.

• 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: 8932483
• Report Number: 2024168-2019-11176
• Device Sequence Number: 16631447
• Product Code: DQX
• UDI-Device Identifier: 08717648032998
• UDI-Public: 08717648032998
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• 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,Followup
• Report Date (Section B): 09/16/2019

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: 04/30/2021
• Device Catalogue Number: 1002703-01
• Device Lot Number: 9051461
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/25/2019
• Initial Date Received by Manufacturer: 08/06/2019
• Supplement Date Received by Manufacturer: 09/10/2019
• Initial Report FDA Received Date: 08/26/2019
• Supplement Report FDA Received Date: 09/16/2019
• 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: DESTINATION SHEATH