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

Model Number N/A

Device Problem Break (1069)

Patient Problem Device Embedded In Tissue or Plaque (3165)

Event Date 07/01/2020

Event Type  Injury  

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 Description

The user facility reported that a piece of the destination sheath came off in the patient.It is unknown how much of the sheath is missing.The estimated blood loss was less than 250cc.The patient was normal and in full recovery.The procedure was successful.Additional information was received on 10jul2020.The procedure being performed was a percutaneous transluminal angioplasty (pta) of the superficial femoral artery (sfa)/pelvic organ prolapse (pop)/ bruton tyrosine kinase (btk).The difficulties with access were heavy calcium, steep bifurcation, and tortuous anatomy.The destination sheath was not removed from the patient.The patient was in stable condition.

Manufacturer Narrative

This report is being submitted as follow up no.1 to provide additional information in section b5, update section h3, and to provide the completed investigation results.One 6fr 45 cm destination sheath was returned for product evaluation.The dilator was not received.No other accessory components were returned.Visual inspection revealed that the stainless-steel coil was exposed at the distal segment of the sheath.Dimensional testing was performed.The total length of the received damaged sheath was measured to be 45.85 cm.The outer diameter of the sheath was measured to be 0.278 cm which is within manufacturer's specifications.X-ray images of the sheath were taken, the images showed that the inner coiling within the sheath had been stretched.Based on the provided information and investigation results, there is no definitive evidence that this event was related to a device defect or malfunction.The exact cause of the reported event cannot be definitively determined based on the available information.

Event Description

Additional information was received on 31aug2020.The piece of the sheath was not retrieved from the patient.The physician did not feel that it was a good option to retrieve it at that time.The patient has not come back for any follow up or procedures.

• Brand Name: RENAL GUIDING SHEATH
• Type of Device: INTRODUCER, CATHETER
• Manufacturer (Section D): TERUMO MEDICAL CORPORATION; 950 elkton blvd.; elkton, md
• MDR Report Key: 10353418
• MDR Text Key: 201426648
• Report Number: 1118880-2020-00180
• Device Sequence Number: 1
• Product Code: DYB
• UDI-Device Identifier: 00389701006161
• UDI-Public: 00389701006161
• 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: 07/31/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/31/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 06/30/2022
• Device Model Number: N/A
• Device Catalogue Number: RSR01
• Device Lot Number: YA01
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/20/2020
• Date Manufacturer Received: 09/09/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other