MAUDE Adverse Event Report: TERUMO MEDICAL CORPORATION RADIFOCUS INTRODUCER II KIT; INTRODUCER, CATHETER

Model Number	N/A
Medical Device Problem Code	Crack (1135)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/04/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Implanted date: device was not implanted.Explanted date: device was not explanted.The actual device has not been returned for evaluation.The investigation is currently ongoing.A follow up report will be submitted once the investigation is complete.
Event or Problem Description
The user facility reported that it was visualized pre-treatment that the radifocus introducer ii kit dilator and sheath tip were cracked right out of the package prior to prepping the device.The procedure was a success.The patient's condition was stable.The device was not used on the patient.There was no patient injury, medical/surgical intervention required, it did not go near the patient.Additional information was received on 09nov2020.The procedure performed was a left heart catheterization.The procedure was completed by using another sheath.
Additional Manufacturer Narrative
This report is being submitted as follow up no.1 to provide the device return date in section d9, and to update section h3.The actual device has been returned for evaluation.The investigation is currently ongoing.A follow up report will be submitted once the investigation is complete.
Additional Manufacturer Narrative
This report is being submitted as follow up no.2 to update section h3, and to provide the completed investigation results.A correction is being provided to the device return date in section d9.The date of return was inadvertently not provided in follow up no.1; therefore, the date has been provided.A review of the device history record of the product code/lot# combination was conducted with no findings.One 4fr pinnacle introducer kit sheath was received for product evaluation.The dilator and sheath were received unmated.Visual inspection of the sheath and dilator revealed that the sheath and dilator were incompletely formed from 13.2 cm until the end of the dilator tip.The sheath was also incompletely formed from 9.4 cm until end of the sheath tip.The complaint can be confirmed for sheath catheter and dilator mechanical damage.A non-conformance has been initiated to investigate the case.Per the investigative report, based on the occurrence rate found for internal and external failures, it can be concluded that this defect/event is isolated.No occurrence threshold was breached per trending analysis.Therefore, the only further action recommended is tracking and trending for future occurrences.

• Brand Name: RADIFOCUS INTRODUCER II KIT
• Common Device Name: INTRODUCER, CATHETER
• Manufacturer (Section D): TERUMO MEDICAL CORPORATION; 950 elkton blvd.; elkton MD 21921
• MDR Report Key: 10895750
• Report Number: 1118880-2020-00311
• Device Sequence Number: 14281685
• Product Code: DYB
• UDI-Device Identifier: 00389701007229
• UDI-Public: 00389701007229
• Combination Product (Y/N): N
• Initial Reporter State: NY
• Initial Reporter Country: US
• PMA/510(K) Number: K954234
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: company representative,user f
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 11/24/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 11/30/2020
• Device Model Number: N/A
• Device Catalogue Number: RSS402
• Device Lot Number: YG17
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/20/2020
• Initial Date Received by Manufacturer: 11/04/2020
• Supplement Date Received by Manufacturer: 11/20/2020; 01/11/2021
• Initial Report FDA Received Date: 11/24/2020
• Supplement Report FDA Received Date: 12/11/2020; 01/19/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1