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	10/26/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Implanted date: device was not implanted; explanted date: device was not explanted.The actual device has 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 when the destination guiding sheath was taken from the package, the sheath was already kinked.The guiding sheath was not used and replaced with another guiding sheath to continue the procedure.Subsequently, the procedure was successfully completed.There was no health damage to the patient.There was no patient injury, medical/surgical intervention required.There were no other devices, or equipment used with the reported product.
Additional Manufacturer Narrative
This report is being submitted as follow up no.1 to update section h3, and to provide the completed investigation results.One 8fr 45 cm destination sheath and dilator were received for product evaluation at terumo medical corporation.The components were received in the packaging tray.Upon visual analysis, the sheath was kinked at 25.8 cm from the hub.No other visual anomalies were noted.Upon visual analysis, the outer diameter of the sheath was noted to be 3.45mm which is within specifications.The complaint can be confirmed for sheath catheter mechanical damage.A nonconformance was generated since the damage was observed when the sheath was taken right out of the package.Per the nonconformance investigation report, there are currently two methods for pushing the sheath into the package.The first is to run the operator's hand along the sheath and push the sheath in as the hand transverses the sheath.The second method is to lay the sheath on the package and push the sheath in at the pinch points.The dent occurred perpendicular to the package in the section between pinch points.Neither production process involves any pressure that would cause the dent to occur in either its location or direction.One method that could cause it was discovered during the investigation.When pulling the sheath out of the package, for use at the customer for example, if the sheath is grasped at the section in between pinch points and pulled out the dent could occur.The best practice is to pull from the hub to remove the sheath.The defect was replicated on a separate sheath when it was pulled out from pinch point instead of the hub.This is likely the cause of the defect.The product that was returned from customer was unsealed further indicating that it was manipulated/compromised.

• 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: 10868838
• Report Number: 1118880-2020-00295
• Device Sequence Number: 3949870
• Product Code: DYB
• UDI-Device Identifier: 00389701009414
• UDI-Public: 00389701009414
• 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
• Report Date (Section B): 11/19/2020

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: 11/30/2022
• Device Model Number: N/A
• Device Catalogue Number: 54-84501
• Device Lot Number: YG10
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/11/2020
• Initial Date Received by Manufacturer: 10/26/2020
• Supplement Date Received by Manufacturer: 01/27/2021
• Initial Report FDA Received Date: 11/19/2020
• Supplement Report FDA Received Date: 01/29/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1