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

Model Number N/A

Device Problem Difficult to Insert (1316)

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

Event Date 03/05/2021

Event Type  Injury  

Manufacturer Narrative

Implanted date: device was not implanted.Explanted date: device was not explanted.The actual device was not returned for evaluation.The investigation is currently ongoing.A follow up report will be submitted once the investigation is complete.The production lot number was not provided by the user facility, which prevented a meaningful review of the device history record.

Event Description

The user facility reported that during a peripheral procedure the destination sheath would not advance through a scarred groin.The precision sheath advanced with no issue.The doctor stated that the transition from the dilator to the sheath was not a smooth transition which caused the sheath to accordion when trying to advance through the scarred groin.A cook ansel sheath was then used but doesn't offer the support he likes with the destination.The patient was unharmed and was stable.The procedure was not successful.Additional information was received on 23mar2021.The statement, "procedure was not successful" only meant the terumo device had to be switched for a cook device.The interventional procedure was completed successfully, however the cook sheath came apart when the doctor was removing it.He was able to get it completely out without surgery, however it was a struggle.

Event Description

Additional information was received on 11may2021.There was only one destination sheath that was attempted to cross the scarred groin.There was heavy resistance while advancing the sheath.The contralateral superficial femoral artery was the vessel being treated.The vessel was scarred.

Manufacturer Narrative

This report is being submitted as follow up no.1 to provide additional information in section b5 and to provide the completed investigation results.The actual device was not returned; therefore, an evaluation of the actual device was unable to be conducted.The complaint cannot be confirmed for sheath catheter and dilator insertion difficulties since the sample was not received.Based on the information given, the exact root cause of the event cannot be determined.Currently, no action is recommended since this risk evaluation is within the predetermined limits in the 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: 11664134
• MDR Text Key: 245363417
• Report Number: 1118880-2021-00075
• Device Sequence Number: 1
• Product Code: DYB
• 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
• Report Date: 04/14/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/14/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: N/A
• Device Catalogue Number: RSR01
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 05/11/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention