MAUDE Adverse Event Report: TERUMO MEDICAL CORPORATION DESTINATION RENAL GUIDING SHEATH; INTRODUCER, CATHETER

Model Number	N/A
Medical Device Problem Code	Material Separation (1562)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/22/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A1: patient identifier: requested, not provided a2: age & date of birth: requested, not provided.A3: patient sex: requested, not provided.A4: weight: requested, not provided.A5: ethnicity: not provided for animal use.A6: race: not provided for animal use.D6a: implanted date: device was not implanted d6b: explanted date: device was not explanted e3: occupation: quality and process excellence analyst 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 the touhy part of the sheath broke off when they removed the percutaneous transluminal angioplasty (pta) balloon.The blood loss was less than 250cc's.The procedure performed was peripheral.The reported event did not result in patient injury and/or medical or surgical intervention.There is not a direct allegation that the reported device caused or contributed to patient injury and/or need for medical intervention.
Additional Manufacturer Narrative
This report is being submitted as follow up no.1 to provide a correction to section d9 and to provide the completed investigation results.As of 07jun2024, the sample was not returned for assessment.If the sample is made available in the future, the complaint record will be reopened and updated.The complaint cannot be confirmed for valve separation because the sample was not returned for assessment.The exact root cause could not be determined.The complaint mentions that the valve separated when withdrawing the pta balloon.The likely root cause of the valve separation is that the balloon became caught on the valve and high tensional forces caused it to break.Review of the device history record (dhr) showed there were no issues noted during manufacture of the product that could have contributed to this complaint condition.Currently no action is recommended since this risk evaluation is within the predetermined limits in the design failure mode and effects analysis (dfmea).

• Brand Name: DESTINATION RENAL GUIDING SHEATH
• Common Device Name: INTRODUCER, CATHETER
• Manufacturer (Section D): TERUMO MEDICAL CORPORATION; 950 elkton blvd.; elkton MD 21921
• Manufacturer (Section G): TERUMO MEDICAL CORPORATION; 950 elkton blvd.; elkton MD 21921
• Manufacturer Contact: gina digioia ; 950 elkton blvd; elkton, MD 21921 ; 4103927218
• MDR Report Key: 19133251
• Report Number: 1118880-2024-00053
• Device Sequence Number: 20546412
• Product Code: DYB
• UDI-Device Identifier: 00389701006222
• UDI-Public: 00389701006222
• Combination Product (Y/N): N
• Initial Reporter State: IL
• Initial Reporter Country: US
• PMA/510(K) Number: K172995
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 04/18/2024

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: 04/01/2024
• Device Model Number: N/A
• Device Catalogue Number: RSR07
• Device Lot Number: 0000101681
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/25/2024
• Supplement Date Received by Manufacturer: 06/10/2024
• Initial Report FDA Received Date: 04/18/2024
• Supplement Report FDA Received Date: 06/28/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 10/13/2021
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown