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

Model Number	N/A
Medical Device Problem Code	Loose or Intermittent Connection (1371)
Health Effect - Clinical Code	Hematoma (1884)
Date of Event	12/27/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
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
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 defective device caused a hematoma.Blood loss less than 250 ccs.The event occurred intra-operative.Medical/surgical intervention was not required.There is 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 sent as follow-up no.1 to provide the completed investigation results.The actual device was not returned; therefore, an evaluation of the actual device was unable to be conducted.The complaint can be confirmed for sheath withdrawal difficulties based on the sequence of events described in the complaint description and need for surgical intervention.Field clinical was consulted and it was confirmed that the destination sheath is not indicated for radial use due to the sheath not being fully hydrophilic and the outer diameter of the sheath being typically too large for use in this anatomy.As the device was used against indications, no failure mode can be attributed to the device itself.There is no indication that any manufacturing, design, or quality system issues may have led to this event.Currently no action is recommended since device was within manufacturing and design specifications when it was released from terumo medical corporation control.

• 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: 18585667
• Report Number: 1118880-2023-00472
• Device Sequence Number: 15576206
• 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
• 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: 04/19/2024
• Initial Report FDA Received Date: 01/26/2024
• Supplement Report FDA Received Date: 05/19/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 07/19/2023
• 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