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

Catalog Number RR-A40K10A

Device Problem Material Puncture/Hole (1504)

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

Event Date 12/27/2021

Event Type  malfunction  

Manufacturer Narrative

Implanted date: device was not implanted.Explanted date: device was not explanted.Pma/510(k)- k062858, k082644.The actual device was not returned for evaluation.A review of the device history record and shipping inspection record of the involved product code/lot# combination was conducted with no findings.Ifu states: do not scratch the sheath with needle point, cutting tool, or other edged tools.As a result of investigating the information for the past three years, several cases for pinholes in the sheath tube in radifocus introducer ii h were found.However, in each case, a sharp object came into contact with the sheath tube, causing a scratch, resulting in a pinhole.Therefore, it was judged that it was not a defect caused by the product.With no device return 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 in the pci procedure, the involved radifocus introducer ll h was inserted from the left femoral.After contralateral injection was performed and the lesion was confirmed, a competitor's angiographic catheter was removed.Then, 10 to 20 minutes after the shifting from the right femoral to pci, bleeding was observed from the left puncture site.When the product was removed, it was found that a pinhole was formed on the sheath tube.The patient had minor harm; did not have serious injury.The procedure outcome was not reported.

• Brand Name: RADIFOCUS INTRODUCER
• 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: mary o'neill ; reg. no. 2243441; 950 elkton blvd.; elkton, MD 21921 ; 8002837866
• MDR Report Key: 13313615
• MDR Text Key: 284172498
• Report Number: 9681834-2022-00001
• 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: Foreign,Health Professional,User Facility,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 01/21/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/21/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 10/31/2023
• Device Catalogue Number: RR-A40K10A
• Device Lot Number: 210512
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/06/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/26/2021
• 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