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

Model Number	N/A
Medical Device Problem Codes	Difficult to Advance (2920); Material Split, Cut or Torn (4008)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/05/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Implanted date: device was not implanted.Explanted date: device was not explanted.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 the destination guiding sheath could not go through the lesion due to severe calcification.The physician withdrew the guiding sheath.The tip of the guiding sheath was found to be split finely.The device was not used and replaced with another destination ex guiding sheath to continue the procedure.Subsequently, the procedure was successfully completed.There was no health damage for the patient.The estimated blood loss was less than 250cc.There were no other devices or equipment used with the reported product.
Additional Manufacturer Narrative
This report is being submitted as follow up no.2 to update section h3, and to provide the completed investigation results.One used 7fr 45 cm destination sheath and dilator were returned for product evaluation.The components were not mated when received.Visual inspection revealed that slight damage was observed at the distal tip of the sheath; no damage was also seen on the dilator.Microscopy confirmed that the sheath tip was slightly damaged in a fashion where there was a small wrinkle on the tip of the sheath rim.Based on the investigation of the returned device, the complaint can be confirmed for sheath catheter tip mechanical damage.The cause of the event is likely due to the severe calcification as stated in the allegation.The device was in a conforming state when released from terumo control.There is no indication that any manufacturing, design or quality system issues may have led to this event.Currently, no action is recommended since this risk evaluation is within the predetermined limits in the fmea.
Additional Manufacturer Narrative
This report is being submitted as follow up no.1 to provide the device return date in section d9, and to update section h3.

• 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: 10767821
• Report Number: 1118880-2020-00261
• Device Sequence Number: 11783926
• Product Code: DYB
• UDI-Device Identifier: 00389701008851
• UDI-Public: 00389701008851
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• 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: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 11/01/2020

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: 10/31/2022
• Device Model Number: N/A
• Device Catalogue Number: 54-74501
• Device Lot Number: YF08
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/02/2020
• Initial Date Received by Manufacturer: 10/05/2020
• Supplement Date Received by Manufacturer: 11/02/2020; 12/14/2020
• Initial Report FDA Received Date: 11/01/2020
• Supplement Report FDA Received Date: 11/21/2020; 12/23/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1