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

Model Number	H74939206070670
Medical Device Problem Code	Material Rupture (1546)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/25/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that there is a hole in the balloon occurred.The patient underwent percutaneous balloon dilation of an artificial arteriovenous fistula in the left forearm, along with thrombolysis of the upper limb vein, performed under local anesthesia.A 7.0 x60, 75cm charger balloon catheter was selected for use.During the procedure, the balloon ruptured, and imaging revealed abnormalities.Upon removal from the patient and flushing with heparinized saline, a visible defect was identified on the balloon.The procedure was completed with another of the same device.There were no patient complaications reported.
Additional Manufacturer Narrative
D2b: product code - lit g4: pma/510(k) # field on 3500a form - k112701, k141521.
Additional Manufacturer Narrative
D2b: product code - lit.G4: pma/510(k) # field on 3500a form - k112701, k141521.Device evaluated by mfr: the device was returned for analysis.A visual examination identified that the balloon was not folded which indicates that the balloon was subjected to positive pressure.A balloon longitudinal tear was identified beginning approximately 20mm distal of the proximal markerband and extending distally across the balloon material to the distal balloon sleeve.The rated burst pressure for this device is 18 atmospheres.A visual and tactile examination found no kinks or damage to the shaft of the device.A visual and tactile examination found no damage to the tip of the device.A visual examination observed no issues with the markerbands of the device.Both markerbands were undamaged in the correct position on the device.No other issues were identified with the device.
Event or Problem Description
It was reported that there is a hole in the balloon occurred.The patient underwent percutaneous balloon dilation of an artificial arteriovenous fistula in the left forearm, along with thrombolysis of the upper limb vein, performed under local anesthesia.A 7.0 x60, 75cm charger balloon catheter was selected for use.During the procedure, the balloon ruptured, and imaging revealed abnormalities.Upon removal from the patient and flushing with heparinized saline, a visible defect was identified on the balloon.The procedure was completed with another of the same device.There were no patient complaications reported.

• 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: 20901274
• Report Number: 2124215-2024-77839
• Device Sequence Number: 12024824
• Product Code: FGE
• UDI-Device Identifier: 08714729804543
• UDI-Public: 08714729804543
• 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): 01/09/2025

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 Expiration Date: 01/19/2026
• Device Model Number: H74939206070670
• Device Catalogue Number: H74939206070670
• Device Lot Number: 0030888608
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/29/2024
• Supplement Date Received by Manufacturer: 12/20/2024
• Initial Report FDA Received Date: 12/11/2024
• Supplement Report FDA Received Date: 01/09/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/20/2023
• 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 Age: 70 YR
• Patient Sex: Male