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

Model Number N/A

Device Problem Peeled/Delaminated (1454)

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

Event Date 07/07/2023

Event Type  malfunction  

Manufacturer Narrative

A1: patient identifier: no patient involvement.A2: age & date of birth: no patient involvement.A3: patient sex: no patient involvement.A4: weight: no patient involvement.A5: ethnicity: no patient involvement.A6: race: no patient involvement.D4: udi: n/a as this product code is not exported to the us market.The actual device has been returned for evaluation.Investigation of the actual sample.Visual inspection of the actual sample revealed that the outer layer had been peeled off and the wire had been exposed in the section from the distal end to approximately 56 mm from the distal end.Total length of wire approximately 800 mm.When it was compared with the normal product, they were equivalent.Therefore, it was inferred that there was no missing part on the wire.No peeling piece from the outer layer was returned.Magnifying inspection of the actual sample was conducted and revealed: (i) it had been scratched in the vicinity of distal end; (ii) the outer layer had been peeled off at approximately 5 mm - 56 mm from the distal end; (iii) in the range of approximately 30 mm - 56 mm from the distal end, the outer layer had been peeled off over half the circumference; (iv) the end on the distal side was straight, and there were steps; (v) the end on the rear end side was arc-shaped, and had a gentle slope; (vi) arc-shaped scratches had been scattered over approximately 61 mm to approximately 76 mm from the distal end; (vii) no anomaly such as a scratch was found in other sections.Electron microscopic inspection of the actual sample was conducted and revealed: (i) the fractured surface of both the scratched sections and the peeled section on the outer layer were smooth; (ii) there was a fixed size cut mark on the top surface of wire.Therefore, it was inferred that there was no missing part on the wire.Measurement of the dimension was performed.The outer diameter of the normal section met the factory's specifications.No anomaly was found.Review of the manufacturing record and the shipping inspection record confirmed that there was not any anomaly in them.A search of the complaint file found no other similar report of the product with the involved product code/lot# from other facilities.We have experienced that when radifocus guide wire m was used in combination with a metal needle, the outer layer was peeled off.When the outer layer was peeled off because it was used in combination with a metal needle, the following characteristics were found.The outer layer was peeled off over half the circumference, and the wire was exposed.The fractured surface of outer layer was smooth.The distal side of peeled outer layer was straight, and there were steps.The rear end side of peeled outer layer was arc-shaped and had a gentle slope.These characteristics were likely to be like those of the actual sample.Cause of occurrence/conclusion as a possible cause of occurrence, was likely that the outer layer was peeled off due to contact with a sharp object.Before the packaging process of this product, 100% visual inspection is performed to confirm that there is no anomaly such as peeling of the outer layer.Therefore, it would be possible to detect anomaly found in the actual sample.Relevant instructions for use (ifu) reference: do not manipulate or withdraw the guidewire m 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.(b)(4).Is submitting this report on behalf of ashitaka factory of terumo corporation (manufacturer) registration no.(b)(4).

Event Description

The user facility reported that the involved device before use, was confirmed that the shaft and coating had peeled off.Therefore, the device was stopped and not used.The event occurred pre-treatment.The patient final impact was not harmed.

Manufacturer Narrative

This report is being sent as follow-up no.1 to correct the information in section d2.The initial mdr submitted inadvertently had the incorrect common device name for the product involved.

• Brand Name: GLIDESHEATH
• 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 ; 6402040886
• MDR Report Key: 17505912
• MDR Text Key: 320910394
• Report Number: 9681834-2023-00154
• 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,Followup
• Report Date: 08/10/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/10/2023
• 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: RF-GA35083
• Device Lot Number: 230214
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/18/2023
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/10/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/21/2022
• 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