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

Model Number	20280
Medical Device Problem Codes	Material Rupture (1546); Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/29/2023
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that balloon rupture and detachment occurred.A non-bsc introducer sheath was inserted.After it was introduced, a 33/7/2/100 equalizer balloon catheter was advanced for post dilatation.However, during the first inflation, the balloon burst.Upon removal of the device, a tear at the ends practically detached from the catheter.The physician completely removed and another equalizer balloon was used to complete the procedure.There were no patient complications reported.
Event or Problem Description
It was reported that balloon rupture and detachment occurred.A non-bsc introducer sheath was inserted.After it was introduced, a 33/7/2/100 equalizer balloon catheter was advanced for post dilatation.However, during the first inflation, the balloon burst.Upon removal of the device, a tear at the ends practically detached from the catheter.The physician completely removed and another equalizer balloon was used to complete the procedure.There were no patient complications reported.
Additional Manufacturer Narrative
Device evaluated by mfr: unit returned in a generic plastic bag with printed batch lot no.Overall visual revision did not identify failures or evidence that could be lost due to the decontamination process.The device was returned, and a visual examination was observed that the balloon was ruptured and detached.Microscopically, it was confirmed the ruptured and detached of the balloon.

• Brand Name: EQUALIZER
• Common Device Name: CATHETER, PERCUTANEOUS
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 300 boston scientific way; marlborough MA 01752
• Manufacturer (Section G): BOSTON SCIENTIFIC CORPORATION; model farm road; cork T12 Y K88; EI T12 YK88
• Manufacturer Contact: rachel shields ; 4100 hamline ave n; arden hills, MN 55112 ; 6512422111
• MDR Report Key: 17633791
• Report Number: 2124215-2023-45100
• Device Sequence Number: 17760612
• Product Code: MJN
• UDI-Device Identifier: 08714729402404
• UDI-Public: 08714729402404
• Combination Product (Y/N): N
• Initial Reporter Country: BR
• 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: Other,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 12/21/2023

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: 02/21/2024
• Device Model Number: 20280
• Device Catalogue Number: 20280
• Device Lot Number: 0030186968
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 08/08/2023
• Supplement Date Received by Manufacturer: 12/07/2023
• Initial Report FDA Received Date: 08/28/2023
• Supplement Report FDA Received Date: 12/21/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/21/2022
• 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
• Concomitant Medical Products and Therapy/Usage Dates: INTRODUCER SHEATH: 20FR DRYSEAL; INTRODUCER SHEATH: 20FR DRYSEAL
• Patient Sex: Unknown