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

Model Number	N/A
Medical Device Problem Code	Peeled/Delaminated (1454)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/09/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Race - american.Implanted date - device not implanted.Explanted date - device not explanted.Reporter occupation - regional director of operations.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.A review of the device history record of the product code/lot# combination was conducted with no findings.
Event or Problem Description
The user facility reported that the doctor could not get destination device up and over.As he pulled it out, the distal end was peeling and would not flush the sheath.The procedure outcome was successful.There was no patient injury, medical/surgical intervention required.Additional information was received on 21july2021: the procedure performed for the patient at the time this event occurred was pad.There were no difficulties with arterial access, sheath, guidewire, or catheter insertion.No other devices were used with the above product.The patient was in stable condition.
Additional Manufacturer Narrative
This report is being submitted as follow up no.1 to report that this reported event has been reassessed and deemed not reportable based upon the investigation of the actual sample.Inspection of the returned sample upon receipt found that the sheath and dilator showed signs of deformation and was not broken or separated.The tip was still attached and was not peeling.The likely root cause for the damage is calcium in the vessel; therefore, this event is currently deemed a nonreportable event.The dhr review determined that the device was in a conforming state when released from terumo control.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 fmea.

• Brand Name: DESTINATION PERIPHERAL GUIDING SHEATH
• Common Device Name: INTRODUCER, CATHETER
• Manufacturer (Section D): TERUMO MEDICAL CORPORATION; 950 elkton blvd.; elkton MD 21921
• MDR Report Key: 12262432
• Report Number: 1118880-2021-00179
• Device Sequence Number: 19750532
• Product Code: DYB
• UDI-Device Identifier: 00389701007793
• UDI-Public: 00389701007793
• Combination Product (Y/N): N
• Initial Reporter State: CA
• 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: company representative,user f
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 08/02/2021

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: 08/31/2022
• Device Model Number: N/A
• Device Catalogue Number: RSP02
• Device Lot Number: YD11
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/21/2021
• Initial Date Received by Manufacturer: 07/09/2021
• Supplement Date Received by Manufacturer: 10/04/2021
• Initial Report FDA Received Date: 08/02/2021
• Supplement Report FDA Received Date: 10/14/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1