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

Model Number N/A

Device Problem Peeled/Delaminated (1454)

Patient Problem Foreign Body In Patient (2687)

Event Date 10/20/2023

Event Type  Injury  

Manufacturer Narrative

G4: pma/510(k): k926214, k923607.Since the actual sample was not returned, investigation of it could not be performed.Based on the description of the event, it was recognized that a metal needle was used in combination with the actual sample.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.Based on our 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.Based on the investigation result, no anomaly was found in the manufacturing record and the shipping inspection record.From the circumstances of the occurrence of this case, it was inferred that the outer layer of the actual sample peeled off because the actual sample and a metal needle were used in combination.However, since the actual sample was not returned and investigation of it could not be performed, it was not possible to clarify the cause of occurrence.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.

Event Description

The user facility reported that the actual product was used in a case of percutaneous transhepatic biliary drainage.The left iliopsoas muscle was punctured with a metal needle and then the actual product was inserted into the metal needle, which resulted in the urethane peeling and remaining in the patient.The current product was used in a procedure to place a drainage tube in order to drain pancreatic juice for a patient who suffered from lower limb movement disorders due to pancreatic juice leaking from a traumatically ruptured pancreas and flowing into the iliopsoas muscle.The procedure was finished without becoming aware of this issue (october 20).Three weeks later, a follow-up computerized tomography (ct) scan showed what appeared to be metal near the drainage tube, and it was discovered that the urethane piece remained inside the patient.There was no bacterial infection (caused by foreign bodies) in the drainage fluid, and there was no sign of the urethane piece having moved in comparison with the image taken immediately after the procedure.The patient's current condition was good.It was difficult to remove the peeled urethane at the time of discovery.As of november 30th, the urethane piece remained in the patient, and it was being considered whether or not to remove it and how to remove it.The event occurred intra-operative.The patient was not seriously harmed.

• 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: 18363479
• MDR Text Key: 330985274
• Report Number: 9681834-2023-00263
• 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: 12/20/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/20/2023
• 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: 230302YA
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/30/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/02/2023
• 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
• Treatment: METAL PUNCTURE NEEDLE
• Patient Outcome(s): Other