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

Model Number N/A

Device Problem Break (1069)

Patient Problem Insufficient Information (4580)

Event Date 07/20/2023

Event Type  malfunction  

Event Description

The user facility reported that the guidewire broke.The device was reported to fail upon initial clinical use.

Manufacturer Narrative

The actual device was not returned; therefore, an evaluation of the actual device was unable to be conducted.1.The manufacturing record and the shipping inspection record of the product of the involved product code/august-2022 lot · no anomaly was found.2.The past complaint file of the involved product code/august-2022 lot · no other similar report from other facilities was found.3.Simulation test (fracture of guidewire) a) when a guidewire was pulled until fractured, the side of fractured part of the core wire was found tapered, and a dimple pattern (a hole-shaped pattern) was found on the fracture surface.B) when a guidewire was torqued clockwise and counterclockwise alternately fractured, the side of the fractured part of the core wire was found flat, and a spiral pattern was found on the fracture surface.C) when a guidewire was bent 90° repeatedly until fractured, the side of the fractured part of the core wire was found oblique, and a radial pattern was found on the facture surface.4.Udi no.: (b)(4).Based on the investigation result, as a possible cause of this case, it was inferred that some excessive tensile, torque, or bending force might have been applied to the actual sample, leading to the reported fracture.However, since the actual sample was not returned, the cause of the occurrence could not be clarified.The instructions for use (ifu) of this product includes the following statement.- if any resistance is felt or if the tip's behavior and/or location seems improper, stop manipulating the guide wire and/or endotherapy accessory and determine the cause by fluoroscopy or endoscope.Continuing to manipulate the guidewire could cause patient injury, such as punctures, hemorrhages or mucous membrane damage.It may also damage the endoscope, instrument and/or endotherapy accessory.Terumo medical products (tmp) (importer) registration no.(b)(4) is submitting this report on behalf of ashitaka factory of terumo corporation (manufacturer) registration no.(b)(4).

• Brand Name: SINGLE USE GUIDWIRE
• Type of Device: ENDOSCOPIC GUIDEWIRE, GASTROENTEROLOGY-UROLOGY
• Manufacturer (Section D): TERUMO CORPORATION, ASHITAKA; 150 maimaigi-cho; fujinomiya city, 418 ; JA 418
• Manufacturer (Section G): TERUMO CORPORATION, ASHITAKA; reg. no. 9681834; 150 maimaigi-cho; fujinomiya city, 418 ; JA 418
• Manufacturer Contact: gina digioia ; 265 davidson ave; suite 320; somerset, NJ 08873 ; 6402040886
• MDR Report Key: 17604015
• MDR Text Key: 321751624
• Report Number: 9681834-2023-00177
• Device Sequence Number: 1
• Product Code: OCY
• UDI-Device Identifier: 04953170358234
• UDI-Public: 04953170358234
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: D456910
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: User Facility,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 08/23/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/23/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: N/A
• Device Catalogue Number: OL-XS25455M
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 07/25/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1