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 Type  Injury  

Manufacturer Narrative

A1: patient identifier: requested, not provided.A2: age & date of birth: requested, not provided.A3: patient sex: requested, not provided.A4: weight: requested, not provided.A5: ethnicity: requested, not provided.A6: race: requested, not provided.B3: date of event: requested, not provided.D4: lot number: requested, unknown.D4: expiration date: unknown due to unknown lot number.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.H4: device manufacture date: unknown due to unknown lot number.Since the actual sample was not returned, investigation of it could not be performed.The metal needle was used in combination with the actual product.Since the lot number was unknown, the manufacturing record, the shipping inspection record, and the past complaint file of the product with the involved product code/lot number could not be investigated.Since the lot number was unknown, the manufacturing record and the shipping inspection record could not be investigated.Simulation test: based on our past knowledge, we have experienced that the outer layer peeled off when using radifocus guide wire m and a metal needle in combination.From the circumstances of the occurrence of this case, it was inferred that since the actual product and metal needle were used in combination, the outer layer peeled off.However, since the actual sample was not returned and investigation 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.(b)(4).

Event Description

The user facility reported that when the guidewire was pulled out, it was felt that the wire got caught.When it was pulled out, it was confirmed that the coating had peeled off.The detached fragments were not removed.Metal needles had been used.Since the peeled piece was not removed from the patient's body, it cannot be denied the possibility that the peeled piece may remain in the patient's body.The procedure outcome was not reported.The final patient impact was not harmed.The event occurred intra-operative.

• 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: 18235821
• MDR Text Key: 329314817
• Report Number: 9681834-2023-00245
• 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: 11/30/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/30/2023
• 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-GA35083
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/09/2023
• 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
• Treatment: METAL NEEDLE
• Patient Outcome(s): Other