MAUDE Adverse Event Report: ASAHI INTECC CO., LTD. ASAHI GRAND SLAM; PTCA GUIDE WIRE

Model Number	N/A
Medical Device Problem Codes	Peeled/Delaminated (1454); Detachment of Device or Device Component (2907)
Health Effect - Clinical Codes	Foreign Body In Patient (2687); Device Embedded In Tissue or Plaque (3165)
Date of Event	06/10/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Manufacturing site: asahi intecc (b)(4).The guide wire was returned for evaluation.Both core wire and coil wire of the returned guide wire were found fractured at approximately 13mm distal to the proximal solder designed to sit at 37mm from the wire tip.Microscopic observation of the fracture site found the fracture surface of the core wire resembled that of the coil wire.Both fracture surfaces were uneven.Observation of the core fracture surface by scanning electronic microscope inferred that the fracture was attributed to bending and tensile stress; cracks made by the applied bending stress propagated inward and the core wire eventually separated by the applied tensile stress.For approximately 45-105mm proximal to the proximal solder, ptfe coating of the wire shaft were circumferentially and intermittently peeled off with longitudinal scratches that were partly observed near the peeled spots.Lot history review revealed no anomaly relating to the reported event.No other similar product experience report was received for this lot.Based on the obtained information and investigation outcome, it was presumed that repeated bending stress generated with wire manipulation was accumulated on the guide wire.When the stress exceeded the product's design limit, it caused both core and coil wires to be cracked and eventually separated by tensile stress generated with wire removal.It was concluded that this event was not attributed to product quality.Instructions for use (ifu) states: [warnings] never push, auger, withdraw, or torque a guidewire that meets the resistance.Torquing or pushing a guidewire against resistance may cause guidewire damage and/or guidewire tip separation or direct damage to a vessel.Resistance may be felt and/or observed under fluoroscopy by noting any bucking of the guidewire tip.If guidewire tip prolapse is observed, do not allow the tip to remain in a prolapsed position; otherwise damage to the guidewire may occur.Determine the cause of resistance under fluoroscopy and take any necessary remedial action; [warning] do not push the guide wire more than necessary to advance the tip through the narrowed part of the vessel.(for example, do not push the guide wire when the distal tip of the guide wire is bent by the force of manipulation.) after crossing the targeted area, do not roughly twist, push or pull the guide wire.If the guide wire is moved excessively, it may be damaged or break apart, which may injure the blood vessel or leave fragments inside the vessel; and, [malfunction and adverse effects] separation of the guide wire.
Event or Problem Description
It was reported that the procedure was performed to treat a lesion in the mildly tortuous and non-calcified lesion in the left anterior descending artery.An asahi guide wire was retracted after an unspecified stent was deployed.Although there was no resistance during advancement or removal, the radiopaque portion of the guide wire became detached.It is unknown why the guide wire detached.The detached portion of the guide wire was located outside the unspecified stent.A 190 cm non-asahi guide wire was advanced to retrieve the separated asahi guide wire.The physician intentionally caused the non-asahi guide wire to become entangled with the detached asahi guide wire.Both guide wires were pulled back together through the previously deployed unspecified stent; however, the guide wires became stuck inside the unspecified stent.The distal portion of the non-asahi guide wire became detached.A second unspecified stent was deployed to crush both detached guide wires against the vessel.The procedure ended at this point.The patient is stable.No damage to the previously deployed stent.There were no adverse patient sequela and no clinically significant delay in the procedure.No additional information was provided.
Additional Manufacturer Narrative
Asahi intecc has determined that the date recorded in block b4 "date of this report" was erroneously reported as the date the report was submitted rather than the date the initial reporter provided the information about the event to the company.Corrective action has been taken to clarify which date should be provided in the report.This supplemental report is intended only to correct the date provided in block b4 to reflect the date the initial reporter provided the information about the event to the company.

• Brand Name: ASAHI GRAND SLAM
• Common Device Name: PTCA GUIDE WIRE
• Manufacturer (Section D): ASAHI INTECC CO., LTD.; 3-100 akatsuki-cho; seto, 489-0 071; JA 489-0071
• MDR Report Key: 8751545
• Report Number: 3003775027-2019-00107
• Device Sequence Number: 2359821
• Product Code: DQX
• UDI-Device Identifier: 04547327055833
• UDI-Public: (01)04547327055833(17)210531(10)180615A111
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: K022762
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: distributor,foreign
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 06/15/2019

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: 05/31/2021
• Device Model Number: N/A
• Device Catalogue Number: AG141002
• Device Lot Number: 180615A111
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/27/2019
• Initial Date Received by Manufacturer: 06/15/2019
• Supplement Date Received by Manufacturer: 06/15/2019
• Initial Report FDA Received Date: 07/01/2019
• Supplement Report FDA Received Date: 01/23/2020
• 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; Disability