MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION OCCLUSION BALLOON CATHETER; CATHETER, PERCUTANEOUS

Model Number	27775
Medical Device Problem Code	Material Rupture (1546)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/16/2021
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported the balloon ruptured.An occlusion balloon was selected for use in a transjugular intrahepatic portosystemic shunt procedure in the liver vein.The anatomy was not tortuous, not calcified, and had no stenosis.During the procedure, the balloon ruptured while being inflated, in the liver vein.The balloon was simply retracted with the guidewire in place, and was replaced with another of the same device.There were no patient complications.
Additional Manufacturer Narrative
Upon receipt at our post market quality assurance laboratory, this occlusion balloon was analyzed.The catheter of the device was carefully inspected, and no damages were found.The balloon of the device was inspected, and it was confirmed to be torn.No further damage was found in the returned device.
Event or Problem Description
It was reported the balloon ruptured.An occlusion balloon was selected for use in a transjugular intrahepatic portosystemic shunt procedure in the liver vein.The anatomy was not tortuous, not calcified, and had no stenosis.During the procedure, the balloon ruptured while being inflated, in the liver vein.The balloon was simply retracted with the guidewire in place, and was replaced with another of the same device.There were no patient complications.

• Brand Name: OCCLUSION BALLOON CATHETER
• Common Device Name: CATHETER, PERCUTANEOUS
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; two scimed place; maple grove MN 55311
• Manufacturer (Section G): BOSTON SCIENTIFIC CORPORATION; model farm road cork; cork IRELA ND; EI IRELAND
• Manufacturer Contact: jay johnson ; two scimed place; maple grove, MN 55311 ; 7634942574
• MDR Report Key: 12917527
• Report Number: 2134265-2021-15129
• Device Sequence Number: 5588972
• Product Code: MJN
• UDI-Device Identifier: 08714729112495
• UDI-Public: 08714729112495
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: K132990
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 01/18/2022

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: 12/14/2022
• Device Model Number: 27775
• Device Catalogue Number: 27775
• Device Lot Number: 0027665142
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/02/2021
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 11/19/2021
• Supplement Date Received by Manufacturer: 12/23/2021
• Initial Report FDA Received Date: 12/02/2021
• Supplement Report FDA Received Date: 01/18/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/14/2021
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown