MAUDE Adverse Event Report: TERUMO CORPORATION, ASHITAKA SINGLE USE GUIDWIRE; ENDOSCOPIC GUIDEWIRE, GASTROENTEROLOGY-UROLOGY

Catalog Number	OL-XA25455M
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	Device Embedded In Tissue or Plaque (3165)
Date of Event	04/07/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
D6: implanted date: device was not implanted d7: explanted date: device was not explanted the status of the device is unknown at this time.The investigation is currently ongoing.A follow up report will be submitted once the investigation is complete.For this reason, evaluation code 11 has been referenced in the conclusions section of h6.A review of the device history record and the shipping inspection records of the involved product code/lot# combination confirmed there was no indication of production-related problem or of discrepancy in the inspection result.A search of the complaint file did not find any other report with the involved product code/lot# combination.Terumo medical products (tmp) (importer) registration no.2243441 is submitting this report on behalf of ashitaka factory of terumo corporation (manufacturer) registration no.9681834.Exemption number e2015022.- attachment: [mw5077670.Pdf].
Event or Problem Description
The user facility reported a fracture on the involved device through an fda mw5077670.The patient underwent an ercp (endoscopic retrograde cholangio-pancreatography) for biliary stent replacement.During the procedure the guide wires tangled in the biliary duct and were unable to be removed.The physician elected to cut off the wires and leave them in place.The needle knife used to trim the wires broke and the lever was retained in the patient.The procedure outcome is unknown.The final patient impact is unknown.
Additional Manufacturer Narrative
The actual device was not returned; therefore, an evaluation of the actual device was unable to be conducted.With no device return the exact cause of the reported event cannot be definitively determined based on the available information.

• Brand Name: SINGLE USE GUIDWIRE
• Common Device Name: ENDOSCOPIC GUIDEWIRE, GASTROENTEROLOGY-UROLOGY
• Manufacturer (Section D): TERUMO CORPORATION, ASHITAKA; 150 maimaigi-cho; fujinomiya city, shizuoka 418 ; JA 418
• MDR Report Key: 7676804
• Report Number: 9681834-2018-00126
• Device Sequence Number: 13665054
• Product Code: OCY
• UDI-Device Identifier: 04953170358241
• UDI-Public: 04953170358241
• Combination Product (Y/N): N
• Initial Reporter State: NC
• Initial Reporter Country: US
• PMA/510(K) Number: K091417
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,other
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 07/11/2018

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: Health Professional
• Device Expiration Date: 11/30/2020
• Device Catalogue Number: OL-XA25455M
• Device Lot Number: 171214
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 06/21/2018
• Supplement Date Received by Manufacturer: 08/22/2018
• Initial Report FDA Received Date: 07/11/2018
• Supplement Report FDA Received Date: 09/10/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: BOSTON SCIENTIFIC RS NEEDLE KNIFE XL; EPIC BILIARY STENTS; BOSTON SCIENTIFIC RS NEEDLE KNIFE XL; EPIC BILIARY STENTS
• Outcome Attributed to Adverse Event: Other