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

Model Number N/A

Device Problem Material Twisted/Bent (2981)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 05/19/2021

Event Type  malfunction  

Manufacturer Narrative

Patient identifier: no patient involvement.Age & date of birth: no patient involvement.Patient sex: no patient involvement.Weight: no patient involvement.Ethnicity: no patient involvement.Race: no patient involvement.Implanted date: device was not implanted.Explanted date: device was not explanted.Occupation: materials coordinator.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 Description

The user facility reported that the destination sheath was already bent upon opening the package.The device was opened during prep.The patient was not present when they discovered the issue.There was no patient injury, medical/surgical intervention required.

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.H6: investigation findings - 3252 is based upon the evaluation of user facility information and the investigation of the returned sample; 213 is based upon the measurements of the returned sample.One used 6fr 90 cm destination sheath and dilator was received for product evaluation.The dilator was not mated to the sheath when received.The valve assembly was not returned.The sheath was subjected to visual analysis and flattened segments were observed.Measurements of the flattened segment was found to be starting at 33 cm below the hub to 34.3 cm.The second segment of the flattened segment started at 68.7.No other visual anomalies were observed on the dilator.The outer diameter of the sheath was measured to be 0.110 in which is within specifications.The inner diameter of the sheath tip is 0.088" which is also within specifications.The complaint can be confirmed for sheath catheter mechanical damage.Based on the information given, the exact root cause of the event cannot be determined.It is likely that the flattening of the sheaths could have occurred at an unknown time due to the application of transverse compressive forces.The source of these forces could not be determined.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 failure mode and effects analysis (fmea).

• Brand Name: DESTINATION RENAL GUIDING SHEATH
• Type of Device: INTRODUCER, CATHETER
• Manufacturer (Section D): TERUMO MEDICAL CORPORATION; 950 elkton blvd.; elkton MD 21921
• MDR Report Key: 11992476
• MDR Text Key: 255980392
• Report Number: 1118880-2021-00136
• Device Sequence Number: 1
• Product Code: DYB
• UDI-Device Identifier: 00038970100596
• UDI-Public: 0038970100596
• Combination Product (y/n): N
• PMA/PMN Number: K172995
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,user f
• Type of Report: Initial,Followup

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/14/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 06/01/2023
• Device Model Number: N/A
• Device Catalogue Number: RSC01
• Device Lot Number: 0000030193
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/29/2021
• Date Manufacturer Received: 06/29/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1