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

Catalog Number	AGH146000J
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/09/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Manufacturing site: (b)(4).Device evaluation could not be performed because the affected device was discarded by the user facility.The provided picture showed that the core had fractured along with elongation of the coil.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 findings on lot history records review, it was presumed that tensile stress generated during removal had likely contributed to fracture of the core as well as elongation of the coil.With the guide wire being trapped by the spasmed vessel, the applied stress would localize and therefore exceed the product design limit.It was conclude that this event was not attributed to product quality.No capa will be taken.Instructions for use (ifu) states: [warnings] 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] breakage of the guide wire.
Event or Problem Description
It was reported that the patient experienced vasospasm during a percutaneous coronary intervention (pci) of the right coronary artery (rca), causing a myocardial infarction (mi).An asahi prowater guide wire became trapped when the vessel spasmed, difficulty was noted when attempting to remove the wire from the spasmed vessel, and upon removal it was noted that the distal portion of the wire (spring coil) became elongated.The patient suffered a mi during the procedure but survived and is stable and discharged after treatment.

• 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
• MDR Report Key: 11662824
• Report Number: 3003775027-2021-00073
• Device Sequence Number: 3128484
• Product Code: DQX
• UDI-Device Identifier: 04547327056182
• UDI-Public: (01)04547327056182(17)230630(10)200709A58A
• Combination Product (Y/N): N
• Initial Reporter State: FL
• 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: distributor,foreign
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 03/24/2021

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: 06/30/2023
• Device Catalogue Number: AGH146000J
• Device Lot Number: 200709A58A
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/24/2021
• Initial Report FDA Received Date: 04/14/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 55 YR
• Patient Weight: 68