MAUDE Adverse Event Report: TERUMO MEDICAL CORPORATION DESTINATION RENAL 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	10/30/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Implanted date: device was not implanted.Explanted date: device was not explanted.This report has been deemed reportable based upon evaluation of the actual device.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.For this reason, investigation conclusions code 11 has been referenced in section h6.A review of the device history record of the product code/lot# combination was conducted with no findings.
Event or Problem Description
Evaluation of the actual sample revealed that the tip of the destination sheath was damaged in a fashion where there are folds and a bulge on the edge of the sheath.The dilator was not damaged.The user facility reported that upon removal of the destination sheath from the casing they discovered the dilator would not flush.The patient's condition was fine, and the procedure was a success.There was no patient injury, medical/surgical intervention required.Additional information was received on 05nov2020.The procedure was a leg angio.They continued by using second same device.They said there was no hole.The patient's condition was stable.Additional information was received on 18dec2020.The dilator would not flush.
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 6fr 45 cm destination sheath and dilator were received for product evaluation.Visual inspection of the dilator and sheath revealed damage at the distal tip of the sheath; no damage was seen on the dilator.Microscopy confirmed that the sheath tip was damaged in a fashion where there were folds on the distal edge of the sheath along with some jagged edges and a bulge and a small tear in the shape of a v-notch were exhibited.The outer diameter of the sheath was also found to be in manufacturer specification.The inner diameter of the dilator was measured to be in manufacturer specification.The complaint can be confirmed for sheath tip mechanical damage.Based on the damage observed, it is likely that the damage on the sheath tip can be attributed to difficulties at the point of insertion, possible due to scar tissue or calcification.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 RENAL GUIDING SHEATH
• Common Device Name: INTRODUCER, CATHETER
• Manufacturer (Section D): TERUMO MEDICAL CORPORATION; 950 elkton blvd.; elkton MD 21921
• MDR Report Key: 11207940
• Report Number: 1118880-2020-00369
• Device Sequence Number: 11784360
• Product Code: DYB
• UDI-Device Identifier: 00389701006161
• UDI-Public: 00389701006161
• Combination Product (Y/N): N
• Initial Reporter State: FL
• 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): 01/21/2021

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: 02/01/2023
• Device Model Number: N/A
• Device Catalogue Number: RSR01
• Device Lot Number: 0000007544
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/10/2020
• Initial Date Received by Manufacturer: 12/30/2020
• Supplement Date Received by Manufacturer: 02/22/2021
• Initial Report FDA Received Date: 01/21/2021
• Supplement Report FDA Received Date: 02/26/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1