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	04/08/2022
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the balloon burst.Vascular access was obtained via femoral artery.The target lesion was located in the visceral area.An occlusion balloon catheter was selected for use.During the procedure, the balloon was advanced through an 8f sheath to occlude the vessel.However, it burst upon first inflation at 10atm within 30 seconds.The device was removed along with the wire assembly and completed the procedure with another of same device.No complications reported and patient was stable post procedure.

• 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 CORK LIMITED; model farm road; cork ; EI
• Manufacturer Contact: jay johnson ; two scimed place; maple grove, MN 55311 ; 7634942574
• MDR Report Key: 14442587
• Report Number: 2134265-2022-05340
• Device Sequence Number: 6417916
• Product Code: MJN
• UDI-Device Identifier: 08714729112495
• UDI-Public: 08714729112495
• Combination Product (Y/N): N
• Initial Reporter Country: IN
• 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,Distributor
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 05/18/2022

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: 01/24/2023
• Device Model Number: 27775
• Device Catalogue Number: 27775
• Device Lot Number: 0027895098
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 04/25/2022
• Initial Report FDA Received Date: 05/19/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 08/24/2021
• 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 Age: 49 YR
• Patient Sex: Male
• Patient Weight: 72 KG