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

Model Number	N/A
Medical Device Problem Codes	Material Separation (1562); Unraveled Material (1664); Physical Resistance/Sticking (4012)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/05/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
The user facility reported that the patient received a percutaneous transluminal angioplasty (pta) of the upper and lower leg.During the procedure the physician noticed a calcified puncture site.After the successful treatment of the different closures, the doctor wanted to pull back the destination guiding sheath.He noticed a higher resistance as he introduced the sheath, due to the calcified puncture site.He increased the force just a little bit and suddenly the sheath tore into two pieces, still connected with the braided inner wire.The distal part was still in the patient and just a little piece showed up over the skin.The physician was able to grab the distal part with a tweezer and pulled it completely out of the patient.After that he removed the 0.035" wire and closed the puncture site with manual compression, not with an angio-seal as mentioned in the report.The patient has been treated as intended.There was no significant delay of the procedure.Additional information was received on 13 apr 2022: the physician did not mention a tortuous anatomy, he mentioned a higher resistance during the insertion and the withdraw due to a calcified vessel.There was no patient spasm when attempting withdraw from anatomy with increased force.The patient condition was stable, as it was understood the patient was not harmed.
Additional Manufacturer Narrative
Implanted date: device was not implanted.Explanted date: device was not explanted.Occupation-nurse manager.(b)(4).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.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 sheath separation because the sample was not returned for assessment.The exact root cause could not be determined.The likely root cause is that the calcified entry site caused resistance during withdrawal of the sheath, and the extra force the physician applied tore the sheath.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 & effects anaylsis (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: stephanie handy ; 950 elkton blvd.; elkton, MD 21921 ; 9499890491
• MDR Report Key: 14332449
• Report Number: 1118880-2022-00031
• Device Sequence Number: 11888454
• Product Code: DYB
• UDI-Device Identifier: 00389701006185
• UDI-Public: 00389701006185
• Combination Product (Y/N): N
• Initial Reporter Country: DA
• 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: Foreign,Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 05/08/2022

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: 01/01/2024
• Device Model Number: N/A
• Device Catalogue Number: RSR03
• Device Lot Number: 0000056968
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/22/2022
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/11/2022
• Supplement Date Received by Manufacturer: 07/14/2022
• Initial Report FDA Received Date: 05/08/2022
• Supplement Report FDA Received Date: 08/02/2022
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 04/01/2020
• 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
• Concomitant Medical Products and Therapy/Usage Dates: 0.035" WIRE.
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 77 YR
• Patient Sex: Male
• Patient Weight: 70 KG