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

Model Number N/A

Device Problem No Apparent Adverse Event (3189)

Patient Problem Pain (1994)

Event Date 11/16/2022

Event Type  malfunction  

Manufacturer Narrative

Udi: n/a as this product code is not exported to the us market.Implanted date: device was not implanted.Explanted date: device was not explanted.Initial reporter occupation: occupation: other.The actual device was not returned; therefore, an evaluation of the actual device was unable to be conducted.Review of the manufacturing record and the shipping inspection record could not be performed due to unknown lot number.Regarding the involved product code (ol-xa25455), no similar cases were reported from other facilities in the past three years (november 2019 - november 2022).As one of the possibilities, it was presumed that the outer layer of the guidewire (urethane resin and ptfe coating) was peeled off, the exposed part of the core wire met the current-carrying part of the papillotome and the current passed the guidewire, which resulted in the reported event.However, the cause of the event could not be clarified because the actual sample was not returned.Relevant instructions for use (ifu) reference: please follow the instructions below when carrying out sphincterotomy with the guidewire in place.Failure to observe these warnings could lead to injury to the patient, operator and/or assistant, and may damage the endoscope, instrument and/or endo therapy accessory.Do not use the instrument in combination with any high-frequency therapeutic device whose electrode is in direct contact with the guidewire.Set the output mode of the electrosurgical unit to "cut" or "blend".Activate the unit after confirming that the cutting wire of the sphincterotome is in contact with the target tissue.Do not withdraw the instrument during a sphincterotomy.Terumo medical products (tmp) (importer) registration no: (b)(4) is submitting this report on behalf of ashitaka factory of (b)(4) corporation (manufacturer) registration no: (b)(4).

Event Description

The user facility reported that during an est case, two g-260-2545a were inserted into the bile duct and the pancreatic duct.To perform papillotomy, the physician energized the disposable 3-lumen papillotome v-system kd-v411m-0720 (olympus) with high frequency current, the patient complained of pain.When the g-260-2545a in the pancreatic duct was removed and then the papillotome was re-energized, the patient did not complain of pain.There was no bleeding due to the use of the product.Drainage was performed and the procedure was completed successfully.The event occurred intra-operative.The final patient impact was harmed but not seriously.Medical or surgical intervention was not required.

• Brand Name: SINGLE USE GUIDWIRE
• Type of Device: 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: gina digioia ; 265 davidson ave; suite 320; somerset, NJ 08873 ; 6402040886
• MDR Report Key: 15983579
• MDR Text Key: 308564647
• Report Number: 9681834-2022-00251
• Device Sequence Number: 1
• Product Code: OCY
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K091417
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,User Facility,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 12/14/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/14/2022
• 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-XA25455
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 11/18/2022
• 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