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

Catalog Number OL-XA25455M

Device Problem Fracture (1260)

Patient Problem Device Embedded In Tissue or Plaque (3165)

Event Date 04/07/2018

Event Type  Injury  

Manufacturer Narrative

Implanted date: device was not implanted.Explanted date: device was not explanted.Initial reporter name: unk.Occupation: unk.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.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.(b)(4).

Event 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.

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
• Type of Device: ENDOSCOPIC GUIDEWIRE, GASTROENTEROLOGY-UROLOGY
• Manufacturer (Section D): TERUMO CORPORATION, ASHITAKA; 150 maimaigi-cho; fujinomiya city, shizuoka 418 ; JA 418
• MDR Report Key: 7676804
• MDR Text Key: 113620854
• Report Number: 9681834-2018-00126
• Device Sequence Number: 1
• Product Code: OCY
• UDI-Device Identifier: 04953170358241
• UDI-Public: 04953170358241
• Combination Product (y/n): N
• PMA/PMN Number: K091417
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,other
• Type of Report: Initial,Followup
• Report Date: 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
• Device Operator: 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 Manufacturer Received: 06/21/2018
• Initial Date FDA Received: 07/11/2018
• Supplement Dates Manufacturer Received: 08/22/2018
• Supplement Dates FDA Received: 09/10/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: BOSTON SCIENTIFIC RS NEEDLE KNIFE XL; EPIC BILIARY STENTS; BOSTON SCIENTIFIC RS NEEDLE KNIFE XL; EPIC BILIARY STENTS
• Patient Outcome(s): Other