MAUDE Adverse Event Report: ASAHI INTECC CO., LTD. ASAHI GLADIUS; PERIPHERAL GUIDE WIRE

Catalog Number	PPW14R300S
Medical Device Problem Code	Peeled/Delaminated (1454)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	01/17/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Manufacturing site: asahi intecc (b)(4).Ingle reporter exemption #e2015028.The subject guide wire was returned for investigation.The returned guide wire had its distal segment deformed in helical shape and its polymer jacket was found intermittently peeled off for approximately 11.5-29.5 cm from the distal wire end.Lot history review revealed no anomaly relating to the reported event and no other similar product experience report was received.Based on the obtained information and investigation outcome, it was concluded that the polymer jacket of the guide wire was scraped and peeled off by the burr of the concomitant atherectomy device when the burr was rotated on the guide wire.Sticking of the concomitant balloon catheter was assumed to be caused by the peeled polymer jacket that increased resistance between the guide wire and catheter lumen.Deformation found on the distal segment of the guide wire might have caused by friction occurred between the guide wire and the occlusion or a concomitant device.Although there was no adverse impact on the patient, damaging of the polymer jacket was too severe to rule out a possibility that the coating fragment(s) might be left in the anatomy.Warnings section of the instructions for use states "do not use the guide wire in combination with catheters (atherectomy catheter, metallic dilator etc.) which metallic part may contact surface of this guide wire.[this guide wire may be damaged or separated.]".
Event or Problem Description
It was reported that the polymer jacket of the subject guide wire was found peeled off during a pci to treat a mildly circumflex and heavily calcified total occlusion in the tibial artery.Ipsilateral right side approach was taken against the at occlusion.After the subject guide wire crossed the occlusion beautifully, the physician intentionally did not exchange the guide wire to an atherectomy wire and atherectomy device was placed over the subject guide wire and spun for a long time since the vessel was very calcified.The physician was aware that the guide wire had a polymer jacket and hydrophillic coating.Atherectomy went well and the physician decided to ballooning.After balloon was inflated multiple times, an attempt was made to remove the guide wire from the balloon catheter.It seemed the devices were stuck on one another.Then the physician removed everything from the patient altogether (balloon and wire) and got the guide wire back through the balloon with effort.When the guide wire was finally pulled out of the balloon catheter, it was noticed that part of the polymer jacket had sheared off.Post run was completed; no distal embolization or material was found in patient.
Additional 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 in date of report to reflect the date the initial reporter provided the information about the event to the company.

• Brand Name: ASAHI GLADIUS
• Common Device Name: PERIPHERAL GUIDE WIRE
• Manufacturer (Section D): ASAHI INTECC CO., LTD.; 3-100 akatsuki-cho; seto, aichi 489-0 071; JA 489-0071
• MDR Report Key: 7275927
• Report Number: 3003775027-2018-00029
• Device Sequence Number: 1892943
• Product Code: DQX
• UDI-Device Identifier: 04547327106665
• UDI-Public: (01)04547327106665(17)200531(10)170626A151
• Combination Product (Y/N): N
• Initial Reporter State: NY
• Initial Reporter Country: US
• PMA/510(K) Number: K150445
• 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): 01/29/2018
• Report Date (Section F): 01/30/2018

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: Physician
• Device Expiration Date: 05/31/2020
• Device Catalogue Number: PPW14R300S
• Device Lot Number: 170626A151
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/29/2018
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 01/17/2018
• Event Location: Hospital
• Date Report to Manufacturer: 01/30/2018
• Initial Date Received by Manufacturer: 01/29/2018
• Supplement Date Received by Manufacturer: 01/29/2018
• Initial Report FDA Received Date: 02/15/2018
• Supplement Report FDA Received Date: 12/26/2019
• 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