MAUDE Adverse Event Report: TERUMO MEDICAL CORPORATION RADIFOCUS GUIDEWIRE; WIRE, GUIDE, CATHETER

Model Number N/A

Device Problems Peeled/Delaminated (1454); Physical Resistance/Sticking (4012)

Patient Problem Foreign Body In Patient (2687)

Event Date 11/02/2023

Event Type  Injury  

Event Description

The user facility reported that a 0.035 angled wire and 18g ptcd needle were used when drainage was performed from the retroperitoneum in a case of a left kidney tumor.There was resistance when trying to pull out the guidewire, however, when the guidewire was combined with a dilator, the resistance disappeared.It was found under fluoroscopy that a 2-3cm rod-like substance remained in the bile duct, and this was confirmed on computerized tomography (ct) images.The substance was left in the patient as is, and there were no problems with the patient's health condition.Surgical intervention to remove the substance will be performed when the patient's condition stabilizes.The peeled piece has been left in the patient.The residue in the patient was planned to be removed.The patient was harmed; however, not seriously.The event occurred intra-operative.

Manufacturer Narrative

D4: udi: n/a as this product code is not exported to the us market.D6a: implanted date: device was not implanted.D6b: explanted date: device was not explanted.G4: pma/510(k): k926214, k923607.The actual device was not available; therefore, investigation of it could not be performed.Based on the circumstances of the occurrence, it was recognized that a metal needle was used in combination.Based on past findings, we are aware that the outer layer may be peeled off when the radifocus guidewire m is used in combination with a metal needle.History investigation of the involved product code/lot number: no anomaly was found in the manufacturing record and the shipping inspection record.No other similar complaint was reported from other facilities.From the investigation result, no anomaly was found in the manufacturing record and the shipping inspection record.In this case, it was considered possible that the outer layer was peeled off due to the actual sample having been used in combination with the metal needle; however, since the actual sample was not returned and analysis of it could not be performed, the cause of the occurrence could not be clarified.Relevant instructions for use (ifu) reference: "do not manipulate or withdraw the glidewire through a metal entry needle or a metal dilator.Manipulation and/or withdrawal through a metal entry needle or a metal dilator may result in destruction and/or separation of the outer polyurethane coating requiring retrieval.A plastic entry needle is recommended when using this wire for initial placement." terumo medical products (tmp) (importer) registration no.2243441 is submitting this report on behalf of ashitaka factory of terumo corporation (manufacturer) registration no.9681834.

• Brand Name: RADIFOCUS GUIDEWIRE
• Type of Device: WIRE, GUIDE, CATHETER
• 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 ; 4103927218
• MDR Report Key: 18299909
• MDR Text Key: 330114724
• Report Number: 9681834-2023-00254
• Device Sequence Number: 1
• Product Code: DQX
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K863138
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,User Facility,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 12/11/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/11/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: N/A
• Device Catalogue Number: RF-GA35153
• Device Lot Number: 230426YA
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/15/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/26/2023
• 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
• Patient Outcome(s): Other