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

Catalog Number	AHW14R004J
Medical Device Problem Codes	Fracture (1260); Unraveled Material (1664)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	05/05/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Manufacturing site: (b)(4).Device investigation could not be performed because the 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 tensile stress generated with wire removal had most likely contributed to the reported coil elongation as the guide wire was being caught and restricted its movement likely by the existing stent.Along with coil elongation, separation of the core possibly occurred.Possible damage on the core could be caused by bending stress and torsion generated with wire manipulation performed in attempts to cross the lesion.It was concluded that this event was not attributed to product quality.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; [warnings] if any resistance is felt due to spasm or the guidewire being bent or trapped while operating the guidewire in the blood vessel or removing it, do not move or torque the guidewire.Stop the procedure.Determine the cause of resistance under fluoroscopy and take appropriate remedial action.If the guidewire is moved excessively, it may break or become damaged, which may cause blood vessel injury or result in fragments being left inside the vessel; [warnings] do not perform stent placement using more than one guide wire or wire operation through stent strut.Otherwise, the stent may be damaged or the guide wire may break or break apart; and, [malfunction and adverse effects] breakage of the guide wire.
Event or Problem Description
Sus voluntary event report (#mw5094427) was received on may 27, 2020.It was reported that the procedure was going well.Wire inserted correctly with no problem.Intervention performed and completed with no issues.Wire was being removed and radiographically showed the wire was being stretched, unraveling.Physician carefully manipulated the wire and it was removed entirely.The target lesion was a moderate to severe isr located in ostial to proximal lad.There were no issues advancing wire.Resistance was met during removal and the wire was unraveling and stretching.The final patient outcome was successful and patient reported as stable during and after the procedure.
Event or Problem Description
Sus voluntary event report (#mw5094427) was received on may 27, 2020.It was reported that the procedure was going well.Wire inserted correctly with no problem.Intervention performed and completed with no issues.Wire was being removed and radiographically showed the wire was being stretched, unraveling.Physician carefully manipulated the wire and it was removed entirely.The target lesion was a moderate to severe isr located in ostial to proximal lad.There were no issues advancing wire.Resistance was met during removal and the wire was unraveling and stretching.The final patient outcome was successful achieved by two drug eluting stents deployed at proximal and distal portion on the existing stent and patient was reported as stable during and after the procedure.
Additional Manufacturer Narrative
The sion blue guide wire was returned for evaluation.The returned guide wire had its coil wire elongated for approximately 100mm from the distal-mid solder that was originally located at 20mm from the tip.Under the elongated coil, the inner coil wire was exposed and the core was found fractured at the distal end of the inner coil wire.The elongated coil wire remained in one piece.Microscopic observation of the fracture end revealed that the core-composing twist wire and straight core wire were tangled together and wrenched off.The coils of the inner coil were disarranged due to accumulated torsion.To observe the distal side of the fracture end, the coil wire was unwound.Both the twist wire and straight core wire were found twisted distal to respective fracture end.Based on the provided information and investigation outcome, it was presumed that torsion generated with wire manipulation performed in attempts to cross the lesion had most likely contributed to the observed core separation as the guide wire was being caught and restricted its movement likely by the existing stent.The reported coil elongation was then occurred by tensile stress generated during removal.It was concluded that this event was not attributed to product quality.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; [warnings] if any resistance is felt due to spasm or the guidewire being bent or trapped while operating the guidewire in the blood vessel or removing it, do not move or torque the guidewire.Stop the procedure.Determine the cause of resistance under fluoroscopy and take appropriate remedial action.If the guidewire is moved excessively, it may break or become damaged, which may cause blood vessel injury or result in fragments being left inside the vessel; [warnings] when torquing the guidewire inside the blood vessel, do not torque continuously in the same direction.This may cause the guidewire to become damaged or break apart, causing injury to the blood vessel or leaving fragments inside the vessel.When torquing the guidewire, rotate it clockwise and counterclockwise alternately.Do not exceed two rotations (720°) in the same direction; [warnings] do not perform stent placement using more than one guide wire or wire operation through stent strut.Otherwise, the stent may be damaged or the guide wire may break or break apart; and, [malfunction and adverse effects] breakage 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: 10141540
• Report Number: 3003775027-2020-00084
• Device Sequence Number: 2392710
• Product Code: DQX
• UDI-Device Identifier: 04547327086240
• UDI-Public: (01)04547327086240(17)220930(10)191002A64A
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K122468
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: distributor,foreign
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 05/27/2020

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: 09/30/2022
• Device Catalogue Number: AHW14R004J
• Device Lot Number: 191002A64A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/13/2020
• Initial Date Received by Manufacturer: 05/27/2020
• Supplement Date Received by Manufacturer: 07/13/2020
• Initial Report FDA Received Date: 06/11/2020
• Supplement Report FDA Received Date: 07/29/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 67 YR
• Patient Weight: 66