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

Catalog Number	AGH146000
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	04/23/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
User facility voluntary medwatch report (mdr report #: mw5117196) was received via the us distributor on may 10, 2023.It was reported that the tip of an asahi prowater guide wire broke off during a percutaneous coronary intervention to treat a heavily calcified 90-99% stenosis in the ostium of the ramus artery arising from the left main (lm).During the procedure, the prowater wire was used in an attempt to place a drug eluting stent.When the prowater wire was protracted, it was noted to have come back and the tip of the wire was seen embolized to the distal ramus.The stent remained partially in the lm.Given the non-obstructive lm disease, further maneuvers were felt to be unsafe.The decision was made to leave the ramus as a ptca alone.Given the wire fragment was very distal, attempts to snare the fragment were felt to be high risk for causing ischemia and vessel injury.It is estimated that the retained fragment measures approximately 2.5 cm.No identified adverse outcomes to date.Patient discharged to home without harm related to this event.
Additional Manufacturer Narrative
Manufacturing site: asahi intecc hanoi co., ltd.Hanoi, vietnam, registration number: 3009121749.Device evaluation could not be performed because the affected device was discarded by the user facility.Lot history review revealed no anomaly relating to the reported event from either lot.No other similar product experience report was received from either lot.Based on the provided information and investigation outcome of the production records, and referring to known similar event, it was presume that stress generated with wire manipulation for stent delivery had likely contributed to separation of the tip of the prowater guide wire.The applied stress would localize and therefore exceed the product design limit because the tip had most likely trapped by the heavily calcified 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.

• Brand Name: PROWATER
• 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: 16971106
• Report Number: 3003775027-2023-00052
• Device Sequence Number: 6575191
• Product Code: DQX
• UDI-Device Identifier: 04547327056120
• UDI-Public: (01)04547327056120(17)251130(10)221207A32A
• Combination Product (Y/N): N
• Initial Reporter State: CO
• Initial Reporter Country: US
• PMA/510(K) Number: K163426
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Distributor
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 05/22/2023

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: 11/30/2025
• Device Catalogue Number: AGH146000
• Device Lot Number: 221207A32A
• 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: 05/10/2023
• Initial Report FDA Received Date: 05/21/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 12/27/2022
• 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 Sex: Unknown