MAUDE Adverse Event Report: TERUMO CORPORATION, ASHITAKA GLIDESHEATH; INTRODUCER, CATHETER

Catalog Number RR-AF4D16H

Device Problem Contamination (1120)

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

Event Date 11/05/2020

Event Type  malfunction  

Manufacturer Narrative

Implanted date: device was not implanted.Explanted date: device was not explanted.Pma/510(k)- k062858, k082644.(b)(4).Twelve unopened sample of the involved product code/lot# were returned or evaluation.Visual inspection revealed the absence of foreign substance including hair inside the packages.No rip or no other damage was observed in the package film or in the package card.Magnifying inspection confirmed that all the samples were securely sealed and no anomaly such as a gap in the seal was found.A review of the device history record and shipping inspection record of the involved product code/lot# combination was conducted with no findings.Based on the provided information and investigation results, there is no definitive evidence that this event was related to a device defect or malfunction.With no return of the actual sample, the exact cause of the reported event cannot be definitively determined based on the available information.(b)(4).

Event Description

The user facility reported that the involved radifocus introducer ll h was used pre-treatment.After an ik kit was opened on the shelf on which it had been stored, the operator took out the device, and then found hair adhered to the valve before using it in the patient.It was changed out with another kit of the same lot.The procedure was continued.The procedure outcome was not reported.The patient was not harmed.

• Brand Name: GLIDESHEATH
• Type of Device: INTRODUCER, CATHETER
• Manufacturer (Section D): TERUMO CORPORATION, ASHITAKA; 150 maimaigi-cho; fujinomiya city, 418 ; JA 418
• Manufacturer (Section G): TERUMO CORPORATION, ASHITAKA; reg. no. 9681834; 150 maimaigi-cho; fujinomiya city, 418 ; JA 418
• Manufacturer Contact: theresa mussaw ; reg. no. 2243441; 950 elkton blvd; elkton, MD 21921 ; 8002837866
• MDR Report Key: 10926544
• MDR Text Key: 250321854
• Report Number: 9681834-2020-00236
• Device Sequence Number: 1
• Product Code: DYB
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K033681
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 12/01/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/01/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 09/30/2022
• Device Catalogue Number: RR-AF4D16H
• Device Lot Number: 200416
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/17/2020
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/06/2020
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/16/2020
• 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