MAUDE Adverse Event Report: ASAHI INTECC CO., LTD. ASAHI PROWATERFLEX; 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	04/05/2019
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 relating to the reported event.No other similar product experience report except for mfr report #: 3003775027-2019-00074 was received from this lot.This similar incident was concluded that it was not attributed to product quality but most likely a torque device.Based on the obtained information and referring to known incidents, it was concluded that a hard and sharp part of the concomitant torque device such as a metal chuck scraped the wire surface and peeled the ptfe coating.There was no indication of product deficiency.Although there were no adverse patient effects reported, a possibility could not be completely ruled out that some ptfe coating fragment(s) might have entered into the vasculature.Malfunction and adverse effects section of the instructions for use (ifu) states abrasion of the guide wire coating.
Event or Problem Description
It was reported that an asahi guide wire was used for about two hours in the procedure to treat a cto in the mid rca.The physician commented that a portion of the wire shaft had no color on it while he did not see any paint coming off.It was on the part of the wire that was outside a few cm proximal to the guide catheter, not in the patient possibly where a torque device was attached.Reportedly no residue was found on the drape.There was no issue with patient outcome related to this event, possible peeling of the ptfe coating.
Additional Manufacturer Narrative
Single reporter exemption #e2015028.The importer report number used for this report was generated from the importer registration number, current year, and sequential number that match the manufacturer report number.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 PROWATERFLEX
• 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: 8542473
• Report Number: 3003775027-2019-00073
• Device Sequence Number: 399971
• Product Code: DQX
• UDI-Device Identifier: 04547327056328
• UDI-Public: (01)04547327056328(17)211231(10)190121X211
• Combination Product (Y/N): N
• Initial Reporter State: OH
• Initial Reporter Country: US
• PMA/510(K) Number: K032615
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: distributor,foreign
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 04/10/2019
• Report Date (Section F): 04/10/2019

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: 12/31/2021
• Device Model Number: N/A
• Device Catalogue Number: AGH147300
• Device Lot Number: 190121X211
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 04/08/2019
• Event Location: Hospital
• Date Report to Manufacturer: 04/10/2019
• Initial Date Received by Manufacturer: 04/10/2019
• Supplement Date Received by Manufacturer: 04/10/2019
• Initial Report FDA Received Date: 04/23/2019
• 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