MAUDE Adverse Event Report: TERUMO CORPORATION, ASHITAKA SINGLE USE GUIDEWIRE; WIRE, GUIDE, CATHETER

Model Number	OL-XA25455M
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Type of Reportable Event	Serious Injury
Event or Problem Description
The user facility reported that the involved visiglide was used in conjunction with an mtw ring knife.An electric current was sent to cause heating in the papillotomy on the handle.There was information that the fractured piece had dislodged into the patient's body, but it had already been retrieved.Therefore, it was inferred that the patient was harmed.The event occurred intra-operative.The patient's final impact was not harmed.
Additional Manufacturer Narrative
Implanted date - device not implanted.Explanted date - device not explanted.Device manufacture date: unknown due to unknown lot number.The actual device was not returned; therefore, an evaluation of the actual device was unable to be conducted.Since the lot number was unknown, the manufacturing record and the shipping inspection record could not be reviewed.Since the lot number was unknown, the complaint file could not be searched.Based on the investigation result, as a possible cause of this complaint, it was inferred that although catching or resistance was felt during the operation, the operation was continued as it was, leading to fracture.However, since the actual product was not returned, the cause of occurrence could not be clarified.Relevant ifu (instructions for use) reference: "if any resistance is felt or if the tip's behavior and/or location seems improper, stop manipulating the guide wire and/or endo therapy 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 endo therapy accessory." (b)(4).

• Brand Name: SINGLE USE GUIDEWIRE
• Common Device Name: WIRE, GUIDE, CATHETER
• 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 ; reg. no. 2243441; 950 elkton blvd; elkton, MD 21921 ; 6402040886
• MDR Report Key: 15511970
• Report Number: 9681834-2022-00193
• Device Sequence Number: 5716285
• Product Code: DQX
• UDI-Device Identifier: 04953170358241
• UDI-Public: 04953170358241
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• 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
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 09/29/2022

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 Model Number: OL-XA25455M
• Device Catalogue Number: G-240-2545S
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/08/2022
• Initial Report FDA Received Date: 09/30/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• 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
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown