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

Catalog Number	AH14R026S
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	Device Embedded In Tissue or Plaque (3165)
Date of Event	04/28/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that an asahi minamo guide wire was broken and retained in the coronary artery during percutaneous coronary intervention to treat a heavily calcified and tortuous sub-total occlusion in the right coronary artery.It occurred during initial wiring of the lesion, before pre-dilatation balloon insertion.No microcatheter was used.The procedure was terminated and unsuccessful.No attempts were made to retrieve the wire tip.The patient remained stable throughout and was discharged home.No additional information available.
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 obtained information and outcome of lot history records review, and referring to known similar events, it was presumed that stress generated with wire manipulation in attempts to cross the complicated lesion had likely contributed to the reported separation of the minamo guide wire.The applies stress would localize and therefore exceed the product design limit when the wire tip was being caught and restricted its movement 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.
Additional Manufacturer Narrative
Patient information (a) and event description (b5) were updated according to the additional information.
Event or Problem Description
It was reported that an asahi minamo guide wire was broken and retained in the coronary artery during percutaneous coronary intervention (pci) to treat a heavily calcified and tortuous sub-total occlusion in the right coronary artery (rca).It occurred during initial wiring of the lesion, before pre-dilatation balloon insertion.No microcatheter was used.The procedure was terminated and unsuccessful.No attempts were made to retrieve the wire tip.The patient remained stable throughout and was discharged home.No additional information available.Uf report # (b)(4) was obtained on (b)(6), 2022 via the us distributor.Following additional information was obtained: a minamo wire was attempted, but given calcification and severe tortuosity, was unable to cannulate the distal vessel.The severe tortuosity and calcification in the rca resulted in shearing of the minamo tip which was retained in the mid-rca at the site of the occlusion.Originally intended procedure: left and right selective coronary angiography.Left heart catheterization.Left ventricular manometry.Attempted pci of mid-rca.Aortography.

• Brand Name: MINAMO
• 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
• Manufacturer (Section G): ASAHI INTECC CO., LTD.; 3-100 akatsuki-cho; seto, aichi 489-0 071; JA 489-0071
• Manufacturer Contact: yukako homma ; 3-100 akatsuki-cho; seto, aichi 489-0-071 ; JA 489-0071
• MDR Report Key: 14441141
• Report Number: 3003775027-2022-00056
• Device Sequence Number: 14927093
• Product Code: DQX
• UDI-Device Identifier: 04547327130745
• UDI-Public: (01)04547327130745(17)221231(10)220125A261
• Combination Product (Y/N): N
• Initial Reporter State: TN
• Initial Reporter Country: US
• PMA/510(K) Number: K190176
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Distributor
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 06/13/2022

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: 12/31/2022
• Device Catalogue Number: AH14R026S
• Device Lot Number: 220125A261
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/02/2022
• Supplement Date Received by Manufacturer: 05/21/2022
• Initial Report FDA Received Date: 05/19/2022
• Supplement Report FDA Received Date: 06/12/2022
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 02/10/2022
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Disability
• Patient Age: 54 YR
• Patient Sex: Male
• Patient Weight: 112 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White