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

Model Number	N/A
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/15/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
The user facility reported that during a cholangiogram, under endoscopic ultrasound (eus) guidance, the puncture was performed via the stomach using a 19 g needle.The guidewire was advanced through the liver in the jejunum.To prevent the wire from changing the position when extracting the cystotome, the guidewire was fixed in the biliary system with a snare, then the cystotome was pulled out.As a result, the guidewire broke about 20 centimeters from the starting point of the metal part.The distal part was remained from the liver into the stomach.The fractured piece fell off inside the patient.The fragment was retrieved with a snare from the stomach and no residue was confirmed.The final patient impact was harmed, but non-serious.The event occurred intra-operative.
Additional Manufacturer Narrative
Implanted date: device was not implanted.Explanted date: device was not explanted.The actual sample was discarded by the involved facility.The actual device was not returned; therefore, an evaluation of the actual device was unable to be conducted.Regarding the involved product code/lot combination, review of the manufacturing record and product-release judgement record found no problem in them.Regarding the involved product code/lot combination, the shipping inspection record was reviewed for the tensile strength of the tip.No anomaly was found.Regarding the involved product code/lot combination, a search of the complaint file found no other similar complaint from other facilities.Mechanism of fracture of the guidewire: it is known from our past simulation tests that the guidewire may be fractured when it has been subjected to one of the force described below.In addition, the state of the fracture of the core wire presents some regularity depending on the mechanism of the fracture.One-way tensile force: the fracture ends become tapered and dimple pattern is observed on the fractured surface.Repeated torque force clockwise and counterclockwise alternatively: the fracture ends are flat and swirling pattern is observed on the fracture surface.Repeated bending force at a 90-degree angle: the fracture ends are inclined and radial pattern is observed on the fracture surface.Based on the investigation results, as one of possible causes, it was inferred that the actual sample was exposed to an excessive force (tensile, torque, or bending) to the involved area while its distal end was fixed with a snare, which resulted in the fracture.Since no actual sample was returned for analysis, the cause of occurrence could not be clarified.(b)(4).

• Brand Name: SINGLE USE GUIDWIRE
• Common Device Name: ENDOSCOPIC GUIDEWIRE, GASTROENTEROLOGY-UROLOGY
• Manufacturer (Section D): TERUMO MEDICAL CORPORATION; 950 elkton blvd.; elkton MD 21921
• Manufacturer (Section G): TERUMO CORPORATION, ASHITAKA; reg. no. 9681834; 150 maimaigi-cho; fujinomiya city, 418 ; JA 418
• Manufacturer Contact: stephanie handy ; 950 elkton blvd.; elkton, MD 21921 ; 9499890491
• MDR Report Key: 15051151
• Report Number: 9681834-2022-00130
• Device Sequence Number: 5314199
• Product Code: OCY
• UDI-Device Identifier: 04953170282805
• UDI-Public: 04953170282805
• Combination Product (Y/N): N
• Initial Reporter Country: SW
• PMA/510(K) Number: K091417
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,User Facility,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 07/19/2022

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: 06/30/2024
• Device Model Number: N/A
• Device Catalogue Number: OL-XA25453M
• Device Lot Number: 210713
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/20/2022
• Initial Report FDA Received Date: 07/19/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 07/13/2021
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: 19 G NEEDLE (BOSTON EXPECT SLIMLINE); MTW-6FR (ENDONOVA)
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown