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

Model Number	54-54501
Medical Device Problem Code	Activation, Positioning or Separation Problem (2906)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/23/2024
Type of Reportable Event	Malfunction
Event or Problem Description
The user facility reported that they had two destination sheaths that the luer lock would not lock.The estimated blood loss was less than 250cc.Additional information was received on 26jul2024: two devices were on the shelf.They used the second one for the procedure and the ir doctor was gentle with it.The luer lock it did seat in there, however, the screw part would not tighten and catch.The procedure being performed was a renal angiogram.The second device, from the same lot number had the same result however they made it work.The patient was unharmed.
Additional Manufacturer Narrative
A1: patient identifier: requested, not provided.A2: age & date of birth: requested, not provided.A3a: patient sex: requested, not provided.A3b: gender: 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.E3: occupation: registered nurse (rn).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 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 cannot be confirmed for valve assembly difficulty because the sample was not returned for assessment.The exact root cause could not be determined.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 PERIPHERAL 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 ; 6402040886
• MDR Report Key: 20019946
• Report Number: 1118880-2024-00123
• Device Sequence Number: 7363941
• Product Code: DYB
• UDI-Device Identifier: 00389701008912
• UDI-Public: (01)00389701008912(17)251201(10)0000375073
• Combination Product (Y/N): N
• Initial Reporter State: IA
• 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: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 08/20/2024

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: 12/01/2025
• Device Model Number: 54-54501
• Device Catalogue Number: 54-54501
• Device Lot Number: 0000375073
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/06/2024
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/23/2024
• Supplement Date Received by Manufacturer: 08/22/2024
• Initial Report FDA Received Date: 08/21/2024
• Supplement Report FDA Received Date: 09/20/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/05/2023
• 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
• Patient Sex: Unknown