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

Model Number	N/A
Medical Device Problem Code	Peeled/Delaminated (1454)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	08/23/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).Device evaluation could not be performed because the device was discarded by the facility.Lot history review revealed no anomaly related to the reported event including ptfe coating adhesiveness.No other similar product experience report was received from this lot.In the production process, namely after the ptfe coating over the shaft is done, coating adhesion test is conducted with each coating lot in order to check the adhesion strength meeting the product's specifications.The ptfe coating adhesion strength of the subject lot was confirmed that it has met all testing criteria.Referring to known similar events, it was presumed that the guide wire was likely used with a concomitant device that had a pointy metal part.When the edge of the metal part contacted the surface of the wire shaft, it might scrape the ptfe coating off.It was concluded that this event was not attributed to product quality.Although there were no adverse patient effects reported, a possibility could not be completely ruled out that some coating fragment(s) might remain in the patient.The instructions for use (ifu) states: - [warnings] if resistance is felt between this guide wire and the other interventional devices while operating this guide wire in the blood vessel, avoid applying excessive force.When abnormal resistance is felt, remove the entire system from the patient's body and determine the cause.Otherwise, the guide wire may break or be damaged and may cause injury to the blood vessel or leave fragments inside the vessel; and, - [malfunction and adverse effects] abrasion of the guide wire coating.
Event or Problem Description
It was reported that a percutaneous coronary intervention was performed to treat a moderately tortuous and calcified lesion in the left main or left anterior descending artery.An asahi prowater guide wire was used and its coating was found come off during usage in the patient.The guide wire was simply taken out and replaced with a new guide wire to presume the procedure.There were no adverse patient effects.
Additional Manufacturer Narrative
Asahi intecc has determined that the date recorded in block b4 "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 in block b4 to reflect the date the initial reporter provided the information about the event to the company.

• Brand Name: ASAHI PROWATER
• Common Device Name: PTCA GUIDE WIRE
• Manufacturer (Section D): ASAHI INTECC CO., LTD.; 3-100 akatsuki-cho; seto, 489-0 071; JA 489-0071
• MDR Report Key: 9107727
• Report Number: 3003775027-2019-00156
• Device Sequence Number: 2430489
• Product Code: DQX
• UDI-Device Identifier: 04547327056120
• UDI-Public: (01)04547327056120(17)210228(10)180324A09A
• Combination Product (Y/N): N
• Initial Reporter State: GA
• Initial Reporter Country: US
• PMA/510(K) Number: K022762
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: distributor,foreign
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 09/10/2019

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: 02/28/2021
• Device Model Number: N/A
• Device Catalogue Number: AGH146000
• Device Lot Number: 180324A09A
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 09/10/2019
• Supplement Date Received by Manufacturer: 09/10/2019
• Initial Report FDA Received Date: 09/23/2019
• Supplement Report FDA Received Date: 01/23/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other