MAUDE Adverse Event Report: ABBOTT VASCULAR HI-TORQUE SUPRA CORE 35 GUIDE WIRE WITH MICROGLIDE COATING

Model Number	1002703-01
Medical Device Problem Codes	Break (1069); Product Quality Problem (1506); Stretched (1601)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/16/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Visual and functional inspection was performed on the returned guide wire.The reported irregular texture and stretched coils were confirmed.Additionally, it was noted that the ribbon coils were unraveled, stretched and separated (not in two separate pieces) distal to the proximal solder.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 and/or complaints reported from this lot.The investigation determined that the reported/noted irregular texture, stretched coils and coil break appears to be related to operational circumstances of the procedure.In this case, based on the reported information and returned analysis, it is likely that manipulation of the guide during unpackaging and/or preparation, the guide wire¿s coils became stretched.Further manipulation of the guide wire likely resulted in the noted coil break and irregular texture.The noted teflon coating damage likely occurred during attempts to advance the guide wire through the sheath or during packing for return analysis.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 possibly when removing the device from the protective packaging, or when getting ready to insert, or when inserting the supra core guide wire into the sheath, the surface felt irregular and either during removal from the protective packaging or sheath, it was noted that the coils were stretched.The device was not used in the patient.There was not adverse patient effect or a clinically significant delay in procedure.Another supracore guide wire was used to continue the procedure.No additional information was provided.Device analysis revealed the ribbon coils were unraveled, stretched and separated (not in two separate pieces) distal to the proximal solder.

• Brand Name: HI-TORQUE SUPRA CORE 35 GUIDE WIRE WITH MICROGLIDE COATING
• Common Device Name: GUIDE WIRE
• Manufacturer (Section D): ABBOTT VASCULAR; 26531 ynez rd.; temecula CA 92591 4628
• MDR Report Key: 12345528
• Report Number: 2024168-2021-07326
• Device Sequence Number: 3735731
• Product Code: DQX
• UDI-Device Identifier: 08717648032998
• UDI-Public: 08717648032998
• Combination Product (Y/N): N
• Initial Reporter Country: SF
• PMA/510(K) Number: K980119
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,distri
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 08/19/2021

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: 11/30/2022
• Device Model Number: 1002703-01
• Device Catalogue Number: 1002703-01
• Device Lot Number: 0122261
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/22/2021
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 08/02/2021
• Initial Report FDA Received Date: 08/19/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 44 YR