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

Model Number	20280
Medical Device Problem Code	Material Rupture (1546)
Health Effect - Clinical Codes	No Known Impact Or Consequence To Patient (2692); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/21/2020
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the balloon ruptured.A 7f 20mm x 100cm equalizer balloon catheter was selected for use in a balloon-occluded retrograde transvenous obliteration (brto) of an 18mm splenorenal shunt.During the procedure, the balloon ruptured while inflating at 4cc.The procedure was completed with another of the same device.No patient complications were reported, and the patient was in stable condition post procedure.
Additional Manufacturer Narrative
Device eval by manufacturer: the returned product upn and lot number matched what was reported by the customer.Visual inspection revealed several kinks along the catheter shaft.The kinks were located approximately at 39 cm, 67.5 cm, 78.5 cm and 93 cm, from the distal tip.The balloon was found to be ruptured.A section of the balloon was detached and it was not returned.The proximal and distal bonds were inspected and were intact.Due to the condition of the returned device a functional inspection was not able to be performed.The distal, medium, and proximal outer dimension catheter measurements were within specification.
Event or Problem Description
It was reported that the balloon ruptured.A 7f 20mm x 100cm equalizer balloon catheter was selected for use in a balloon-occluded retrograde transvenous obliteration (brto) of an 18mm splenorenal shunt.During the procedure, the balloon ruptured while inflating at 4cc.The procedure was completed with another of the same device.No patient complications were reported, and the patient was in stable condition post procedure.

• Brand Name: EQUALIZER
• Common Device Name: CATHETER, PERCUTANEOUS
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; two scimed place; maple grove MN 55311
• MDR Report Key: 11148224
• Report Number: 2134265-2021-00108
• Device Sequence Number: 3658787
• Product Code: MJN
• UDI-Device Identifier: 08714729402367
• UDI-Public: 08714729402367
• Combination Product (Y/N): N
• Initial Reporter Country: IN
• PMA/510(K) Number: K140273
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: company representative,distri
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 03/12/2021

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: 01/04/2022
• Device Model Number: 20280
• Device Catalogue Number: 20280
• Device Lot Number: 0025806463
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/11/2021
• Initial Date Received by Manufacturer: 12/30/2020
• Supplement Date Received by Manufacturer: 02/22/2021
• Initial Report FDA Received Date: 01/11/2021
• Supplement Report FDA Received Date: 03/12/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 39 YR