MAUDE Adverse Event Report: BOLTON MEDICAL, INC. RELAY THORACIC STENT-GRAFT WITH PLUS DELIVERY SYSTEM; STENT, ENDOVASCUALR GRAFT, AORTIC

Catalog Number 28-M3462504602690U

Device Problems Device Damaged Prior to Use (2284); Material Split, Cut or Torn (4008)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 01/24/2019

Event Type  malfunction  

Event Description

"when the physician was about to insert the device into the patient's femoral artery, a split was observed on the tip of the outer sheath.The physician stated that the device was treated with care following instructions and no stress that could cause the split was given to the device during setup and priming.The physician assumed that the device had originally been defective.Operation type: tevar (zone 2).(tc# (b)(4)).((b)(4)).Alternative device was used on the patient: 28-m3 46 250 46 26 90u, s/n# (b)(4); 28-m3 46 200 46 26 90u, s/n# (b)(4)".Patient outcome: "neither health problems nor complications were confirmed".

Manufacturer Narrative

Attachment: [mdr 2247858-2019-00008 evaluation.Pdf].

Event Description

"when the physician was about to insert the device into the patient's femoral artery, a split was observed on the tip of the outer sheath.The physician stated that the device was treated with care following instructions and no stress that could cause the split was given to the device during setup and priming.The physician assumed that the device had originally been defective." operation type: tevar (zone 2).(tc#: (b)(4)).(product code#: au-4625046) alternative device was used on the patient: catalog #: 28-m3 46 250 46 26 90u s/n#: (b)(6); catalog #: 28-m3 46 200 46 26 90u s/n#: (b)(6).Patient outcome: "neither health problems nor complications were confirmed.".

• Brand Name: RELAY THORACIC STENT-GRAFT WITH PLUS DELIVERY SYSTEM
• Type of Device: STENT, ENDOVASCUALR GRAFT, AORTIC
• Manufacturer (Section D): BOLTON MEDICAL, INC.; 799 international parkway; sunrise FL 33325
• MDR Report Key: 8355888
• MDR Text Key: 137293064
• Report Number: 2247858-2019-00008
• Device Sequence Number: 1
• Product Code: MIH
• Combination Product (y/n): N
• PMA/PMN Number: P110038
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign
• Type of Report: Initial,Followup
• Report Date: 09/09/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/20/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 03/20/2020
• Device Catalogue Number: 28-M3462504602690U
• Device Lot Number: 160916115
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 01/25/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1