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

Model Number	N/A
Medical Device Problem Code	Material Deformation (2976)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/09/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Implanted date: device was not implanted.Explanted date: device was not explanted.Occupation - unknown.The actual device has not 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 there was difficulty placing the destination dilator into the sheath.Upon inspection it was noted that part of the sheath midway was crushed.Surgeons put the sheath aside for return.There were no issues with the replacement sheath.The vascular surgery procedure was n atherectomy and stent of the superficial femoral artery (sfa).Additional information was received on 15feb2021.The customer swapped out to a new terumo destination sheath.
Additional Manufacturer Narrative
This report is being submitted as follow up no.1 to provide the device return date in section d9, update section h3, and to provide the completed investigation results.One used 8fr 65 cm destination sheath and dilator were returned for product evaluation.The dilator was partially mated to the sheath when received.Visual inspection revealed that the sheath had a flattened segment.Measurements of the flattened segment was found to be starting at 55cm and ending at 57cm from the hub.A slight bend on the dilator was also observed.The dilator was partially mated with 10cm from the dilator hub sticking out of the sheath.No other visual anomalies were observed.The complaint can be confirmed for sheath mechanical damage as it is likely that the flattening of the sheaths occurred due to the application of transverse compressive forces.The source of these forces could not be determined.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: 11440464
• Report Number: 1118880-2021-00031
• Device Sequence Number: 4040938
• Product Code: DYB
• UDI-Device Identifier: 00389701009438
• UDI-Public: 00389701009438
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• 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,foreig
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 03/08/2021

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: 08/31/2021
• Device Model Number: N/A
• Device Catalogue Number: 54-86501
• Device Lot Number: XD20
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/11/2021
• Initial Date Received by Manufacturer: 02/09/2021
• Supplement Date Received by Manufacturer: 03/11/2021
• Initial Report FDA Received Date: 03/08/2021
• Supplement Report FDA Received Date: 04/08/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1