MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION CHARGER; STENTS, DRAINS AND DILATORS FOR THE BILIARY DUCTS

Model Number	H74939206080810
Medical Device Problem Code	Material Rupture (1546)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/08/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A2 - age at time of event: patient is 18 years or older.D2b - pro code (product code): lit.E1 - initial reporter address 1: (b)(6).G4 - premarket / 510(k) #: k112701, k141521.
Event or Problem Description
It was reported that balloon rupture occurred.The 90% stenosed target lesion was located in the non-tortuous and severely calcified brachial artery.An 8.0 x80, 135cm charger balloon catheter was advanced for dilatation.However, during inflation at 10 atmospheres, the balloon ruptured.The procedure was completed with another of same device.No patient complications were reported, and the patient status was stable.
Additional Manufacturer Narrative
A2 - age at time of event: patient is 18 years or older.D2b - pro code (product code): lit.E1 - initial reporter address 1: (b)(6).G4 - premarket / 510(k) #: k112701, k141521.Device evaluated by mfr: the charger was returned for analysis.A visual examination identified that the balloon was not folded which indicates that the balloon was subjected to positive pressure.The rated burst pressure for this device is 18 atmospheres.The returned device was attached to an encore inflation unit.Positive pressure was applied when liquid was observed to be leaking from a balloon pinhole located approximately 45mm distal from the proximal markerband.A visual and microscopic examination of the markerbands identified no issues.A visual and tactile examination identified no kinks or damage to the shaft.A visual and tactile examination identified no damage to the tip of the device.No other issues were identified with the device.
Event or Problem Description
It was reported that balloon rupture occurred.The 90% stenosed target lesion was located in the non-tortuous and severely calcified brachial artery.An 8.0 x80, 135cm charger balloon catheter was advanced for dilatation.However, during inflation at 10 atmospheres, the balloon ruptured.The procedure was completed with another of same device.No patient complications were reported, and the patient status was stable.It was further reported that 80% stenosed target lesion was located in the mildly tortuous and moderately calcified vessel.

• Brand Name: CHARGER
• Common Device Name: STENTS, DRAINS AND DILATORS FOR THE BILIARY DUCTS
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 300 boston scientific way; marlborough MA 01752
• Manufacturer (Section G): BOSTON SCIENTIFIC CORPORATION; pmt 741 persiaran cassia selat; bandarcassia, pulau pinan 14110 ; MY 14110
• Manufacturer Contact: rachel shields ; 4100 hamline ave n; arden hills, MN 55112 ; 6512422111
• MDR Report Key: 21324861
• Report Number: 2124215-2025-06442
• Device Sequence Number: 12729124
• Product Code: FGE
• UDI-Device Identifier: 08714729804697
• UDI-Public: 08714729804697
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: K112697
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Health Professional,Company Representative,Distributor
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 03/07/2025

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 Model Number: H74939206080810
• Device Catalogue Number: H74939206080810
• Device Lot Number: 0033063835
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/06/2025
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/13/2025
• Supplement Date Received by Manufacturer: 02/13/2025
• Initial Report FDA Received Date: 02/06/2025
• Supplement Report FDA Received Date: 03/07/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/18/2023
• 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