MAUDE Adverse Event Report: ASAHI INTECC CO., LTD. SION BLUE; PTCA GUIDE WIRE

Catalog Number	AHW14R304S
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	06/13/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Manufacturing site: (b)(4).Device evaluation could not be performed because the affected device was not returned.Lot history review revealed no anomaly relating to the reported event.No other similar product experience report was received from this lot.Based on the provided information and referring to known similar events, it was presumed that stress generated with wire removal had likely caused the reported separation of the tip of the sion blue guide wire.The applied stress would exceed the product design limit when the tip was being trapped and restricted its movement likely by the existing stent or calcium in the lesion.It was concluded that this event was not attributed to product quality.No capa will be taken.Instructions for use (ifu) states: [warnings] observe movement of this guide wire in the vessels.Before this guide wire is moved or torqued, the tip movement should be examined and monitored under fluoroscopy.Do not move or torque the guide wire without observing corresponding movement of the tip; otherwise, the guide wire may be damaged and/or trauma may occur.In addition, ensure that the distal tip of this guide wire and its location in the vessel are visible during manipulations of the guide wire.Never push, auger, withdraw, or torque this guide wire that meets resistance.Torquing or pushing this guide wire against resistance may cause damage and/or tip separation of this guide wire or direct damage to a vessel.Resistance may be felt and/or observed under fluoroscopy by noting any buckling of the guide wire.If the prolapse of the guide wire tip is observed, do not allow the tip to remain in a prolapsed position; otherwise damage to the guide wire may occur.Determine the cause of resistance under fluoroscopy and take any necessary remedial action.If resistance is felt due to spasm, bending of the guide wire, or due to trap while operating this guide wire in the blood vessel or removing it, do not torque and/or pull the guide wire itself.Stop the procedure.Determine the cause of resistance under fluoroscopy and take appropriate remedial action.If the guide wire is moved excessively, it may break or become damaged, which may cause blood vessel injury or result in fragments being left inside the vessel.[malfunction and adverse effects] separation of the guide wire.
Event or Problem Description
Uf report #: (b)(4) was received from the us importer.It was reported as follows: physician was performing a cardiac procedure with a guidewire that was inserted to balloon a coronary artery (target was a calcified lesion in the left anterior descending artery).Upon removal of the guidewire, it was noted that a tip of the wire had fractured and a small piece was left in the artery per physician instructions.The tip was unfortunately not retrieved due to potential further complications.The procedure was completed; however, the patient was transferred to another hospital for further evaluation and observation due to the fractured tip and due to potential thrombosis.Although the tip was not removed, the patient has since recovered and follows up with the physician monthly.
Additional Manufacturer Narrative
The sion blue guide wire was returned for evaluation.Tip separation was confirmed on the returned guide wire.The fractured coil was found elongated for approximately 155mm from the distal-mid solder that was originally located at 25mm from the tip.At the distal end of the exposed inner coil, core composing wires (straight core wire and twist wire) were twisted off together.Row of the inner coil was misaligned due to accumulated torsion.The fracture end of the coil was necked, indicating tensile stress had caused the coil to fracture.Based on the obtained information and investigation outcome, it was presumed that repeated torsional stress generated with torquing manipulation had most likely caused the observed core fracture on the returned sion blue guide wire.The applied stress would exceed the product design limit when the tip was being trapped and restricted its movement likely by the existing stent or calcium in the lesion.Further applied tensile stress generated with removal then made the coil become elongated and fractured, leading the tip to separate from the body.It was concluded that this event was not attributed to product quality.No capa will be taken.Instructions for use (ifu) states: [warnings]: observe movement of this guide wire in the vessels.Before this guide wire is moved or torqued, the tip movement should be examined and monitored under fluoroscopy.Do not move or torque the guide wire without observing corresponding movement of the tip; otherwise, the guide wire may be damaged and/or trauma may occur.In addition, ensure that the distal tip of this guide wire and its location in the vessel are visible during manipulations of the guide wire.Never push, auger, withdraw, or torque this guide wire that meets resistance.Torquing or pushing this guide wire against resistance may cause damage and/or tip separation of this guide wire or direct damage to a vessel.Resistance may be felt and/or observed under fluoroscopy by noting any buckling of the guide wire.If the prolapse of the guide wire tip is observed, do not allow the tip to remain in a prolapsed position; otherwise damage to the guide wire may occur.Determine the cause of resistance under fluoroscopy and take any necessary remedial action.If resistance is felt due to spasm, bending of the guide wire, or due to trap while operating this guide wire in the blood vessel or removing it, do not torque and/or pull the guide wire itself.Stop the procedure.Determine the cause of resistance under fluoroscopy and take appropriate remedial action.If the guide wire is moved excessively, it may break or become damaged, which may cause blood vessel injury or result in fragments being left inside the vessel.When torquing this guide wire inside the blood vessel, do not torque continuously in the same direction.This may cause the guide wire to become damaged or break apart, causing injury to the blood vessel or leaving fragments inside the vessel.When torquing the guide wire, rotate it clockwise and counterclockwise alternately.Do not exceed two rotations (720 degrees) in the same direction.[malfunction and adverse effects].Separation of the guide wire.

• Brand Name: SION BLUE
• Common Device Name: PTCA GUIDE WIRE
• Manufacturer (Section D): ASAHI INTECC CO., LTD.; 3-100 akatsuki-cho; seto, aichi 489-0 071; JA 489-0071
• MDR Report Key: 12178929
• Report Number: 3003775027-2021-00132
• Device Sequence Number: 1632233
• Product Code: DQX
• UDI-Device Identifier: 04547327086233
• UDI-Public: (01)04547327086233(17)220930(10)191005A37A
• Combination Product (Y/N): N
• Initial Reporter State: PA
• Initial Reporter Country: US
• PMA/510(K) Number: K191464
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: distributor,foreign
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 07/02/2021

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: 09/30/2022
• Device Catalogue Number: AHW14R304S
• Device Lot Number: 191005A37
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/21/2021
• Initial Date Received by Manufacturer: 07/01/2021
• Supplement Date Received by Manufacturer: 07/21/2021
• Initial Report FDA Received Date: 07/16/2021
• Supplement Report FDA Received Date: 08/13/2021
• 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: Disability
• Patient Age: 58 YR