MAUDE Adverse Event Report: ASAHI INTECC CO., LTD. ASAHI CONFIANZA PRO 12; PTCA GUIDE WIRE

Catalog Number AGH143091

Device Problem Break (1069)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 12/14/2018

Event Type  malfunction  

Manufacturer Narrative

(b)(4).The returned guide wire had its coil wire unraveled and fractured proximal to the mid solder.The fracture surface was relatively flat that indicated torsion generated when the coils got straightened had contributed to this fracture.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 investigation outcome, it was concluded that torsion exceeding the product's design limit was accumulated at the mid solder, causing the coil wire to become loose and eventually fractured.There was no indication of product deficiency.Instructions for use (ifu) states: [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 degrees) in the same direction; and, [adverse reactions/events] breakage of this guide wire.

Event Description

It was reported that an asahi guide wire became unraveled during a ppi to treat a moderately calcified cto in the right sfa.The guide wire crossed the lesion with a support catheter when unraveling of the coils were recognized under the fluoroscopy.A new guide wire was replaced to resume the procedure.The ppi was successfully completed with reestablished blood flow.The patient was without problem after the procedure.

Manufacturer Narrative

Asahi intecc has determined that the date recorded in "date of this report" was erroneously reported as the date the report was submitted rather than the date the initial reporter provided the information about the event to the company.Corrective action has been taken to clarify which date should be provided in the report.This supplemental report is intended only to correct the date provided to reflect the date the initial reporter provided the information about the event to the company.

• Brand Name: ASAHI CONFIANZA PRO 12
• Type of Device: 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: 8198564
• MDR Text Key: 131941189
• Report Number: 3003775027-2018-00232
• Device Sequence Number: 1
• Product Code: DQX
• UDI-Device Identifier: 04547327067164
• UDI-Public: (01)04547327067164(17)190930(30)1(10)161019A54A
• Combination Product (y/n): N
• PMA/PMN Number: K052339
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor
• Type of Report: Initial,Followup
• Report Date: 12/17/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/27/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 09/30/2019
• Device Catalogue Number: AGH143091
• Device Lot Number: 161019A54A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/20/2018
• Date Manufacturer Received: 12/17/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1