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

Model Number	N/A
Medical Device Problem Code	Leak/Splash (1354)
Health Effect - Clinical Code	Hematoma (1884)
Date of Event	12/27/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
The user facility reported that during the procedure it was discovered that the hub of the destination sheath would not tighten adequately and as normal and as a result leaked blood.Another destination sheath with a different lot number was opened but was also found to have the same issue.Finally, a competitor device, manufactured by cordis, was used with success.The doctor stated that the device caused a hematoma.He could not explain how or why the device may have caused this.The estimated blood loss was less than 250cc.
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: requested, not provided a6: race: requested, not provided d6a: implanted date: device was not implanted d6b: explanted date: device was not explanted the actual device is not available for return.The investigation is currently ongoing.A follow-up report will be submitted once the investigation is complete.
Event or Problem Description
Additional information was received on 08feb2024: the procedure taking place when the leakage occurred because of valve disconnect was cardiac catheterization.The patient had a lot of tortuosity which was why the doctor chose the size of the destination (ds) sheath he did, however they were leaking multiple times, and a very small hematoma occurred during the multiple exchanges of devices.The hematoma was resolved with manual pressure and the patient was in stable condition.
Additional Manufacturer Narrative
This report is being sent as follow-up no.1 to provide additional information to section b5.The investigation is currently ongoing.A follow-up report will be submitted once the investigation is complete.
Additional Manufacturer Narrative
The actual device was not returned; therefore, an evaluation of the actual device was unable to be conducted.The complaint cannot be confirmed for valve leakage because the complaint sample was not returned for assessment.The exact root cause could not be determined.Historically, valve leakages have been caused by off-center insertion of the dilator.Review of 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).
Additional Manufacturer Narrative
This report is being submitted as follow up no.3 to provide a correction to the summary that was previously provided in section h11 for this report.Please see the corrected summary below: the complaint cannot be confirmed for valve leakage because the complaint sample was not returned for assessment.The exact root cause could not be determined.The likely root cause of the leakage is the user not tightening the valve prior to the procedure.Review of the devcie history record (dhr) showed there were no issues noted during the manufacture of the product that could have contributed to this complaint condition there is no indication that any manufacturing issues may have led to this event.Currently no action is recommended since this risk evaluation is within the predetermined limits in the failure mode and effects analysis (fmea).

• 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 ; 265 davidson ave; suite 320; somerset, NJ 08873 ; 6402040886
• MDR Report Key: 18591546
• Report Number: 1118880-2023-00477
• Device Sequence Number: 20878724
• Product Code: DYB
• UDI-Device Identifier: 00389701006161
• UDI-Public: 00389701006161
• Combination Product (Y/N): N
• Initial Reporter State: NY
• 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: Physician
• Type of Report: Initial,Followup,Followup,Followup
• Report Date (Section B): 01/26/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 04/01/2026
• Device Model Number: N/A
• Device Catalogue Number: RSR01
• Device Lot Number: 0000430029
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/27/2023
• Supplement Date Received by Manufacturer: 02/08/2024; 03/12/2024; 12/20/2024
• Initial Report FDA Received Date: 01/26/2024
• Supplement Report FDA Received Date: 03/05/2024; 04/11/2024; 01/02/2025
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 06/19/2023
• 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
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown