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

Model Number N/A

Device Problem Peeled/Delaminated (1454)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 02/02/2024

Event Type  malfunction  

Event Description

The user facility reported that during endoscopic retrograde cholangiopancreatography (ercp) procedure, it was confirmed that the coating of guidewire had peeled off when inserting g-260-2545a into the endoscope (jf-260v).The guidewire was replaced with another one and the procedure was completed.No harm to the patient reported.

Manufacturer Narrative

A1: patient identifier: requested, not provided.A2: age & date of birth: requested, not provided.A3a: patient sex: requested, not provided.A3b: gender: unknown.A4: weight: requested, not provided.A5: ethnicity: requested, not provided.A6: race: requested, not provided.D4: udi: n/a at this product code is not exported to the us market.D6a: implanted date: device was not implanted.D6b: explanted date: device was not explanted.E1: initial reporter name: unknown.E2: health professional: unknown.E3: occupation: unknown.Since it was unknown whether the actual sample was contaminated by infectious agents, visual inspection was performed from the outside of plastic bag.1.Visual inspection of the actual sample from the outside of plastic bag the section where the user put on the sticky note was confirmed.It was found that there was a part without coating.The part without coating was approximately 25mm.No anomaly such as peeling of the outer layer was found in other sections that could be confirmed.* there is a section in the vicinity of the joint of wire on the involved product (approximately 1330mm - 1355mm from the distal end) that is not coated with ptfe.- it was inferred that "the coating of guidewire had peeled off" described in the complaint form was likely to be an uncoated section in the vicinity of the joint, which exists due to the manufacturing process.2.History investigation of the product with the involved product code/lot# · no anomaly was found in the manufacturing record and the shipping inspection record.· no other similar report due to the manufacturing defect was found in the past.3.Cause of occurrence/conclusion based on the investigation result, no anomaly was found in the manufacturing record and the shipping inspection record.It was inferred that "the coating of guidewire had peeled off" described in the complaint form was likely to be an uncoated section at the joint of wire at approx.1330mm - 1355mm from the distal end.However, since it was unknown whether the actual sample was contaminated by infectious agents, and detailed investigation could not be performed, it was not possible to determine the cause of occurrence.Relevant instructions for use (ifu) reference: "before use, prepare and inspect the instrument as instructed below.Should the slightest irregularity be suspected, do not use the instrument; use a spare instead.Damage or irregularity may compromise patient." terumo medical products (tmp) (importer) registration no.(b)(4) is submitting this report on behalf of ashitaka factory of terumo corporation (manufacturer) registration no.(b)(4).

• Brand Name: SINGLE USE 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: 18902842
• MDR Text Key: 337788042
• Report Number: 9681834-2024-00030
• Device Sequence Number: 1
• Product Code: DQX
• 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: 03/14/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/14/2024
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 05/31/2023
• Device Model Number: N/A
• Device Catalogue Number: OL-XA25455
• Device Lot Number: 36K(230626)
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/15/2024
• Date Manufacturer Received: 02/14/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/26/2023
• 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
• Treatment: JF-260V