MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION CHARGER; CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINAL

Model Number	24681
Medical Device Problem Code	Material Rupture (1546)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/12/2023
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that balloon rupture occurred.The target lesion was located in the thoracic aorta.An 8.0 x40, 135cm charger balloon catheter was advanced for dilation.During the procedure, the balloon ruptured.The procedure was completed with a new balloon.No complications were reported, and the patient's status was stable.
Event or Problem Description
It was reported that balloon rupture occurred.The target lesion was located in the thoracic aorta.An 8.0 x40, 135cm charger balloon catheter was advanced for dilation.During the procedure, the balloon ruptured.The procedure was completed with a new balloon.No complications were reported, and the patient's status was stable.
Additional Manufacturer Narrative
Device evaluated by mfr.: a visual examination identified that the balloon was not tightly folded and had been subjected to positive pressure.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 5mm distal of the distal markerband.No other issues were noted with the balloon material.The rated burst pressure for this device is 18 atmospheres.A visual and tactile examination identified no issues with the shaft, markerbands or the tip of the device.

• Brand Name: CHARGER
• Common Device Name: CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINAL
• 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: 18476513
• Report Number: 2124215-2023-74659
• Device Sequence Number: 15189535
• Product Code: FGE
• UDI-Device Identifier: 08714729804666
• UDI-Public: 08714729804666
• 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): 02/19/2024

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: 08/29/2025
• Device Model Number: 24681
• Device Catalogue Number: 24681
• Device Lot Number: 0030050444
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 12/14/2023
• Supplement Date Received by Manufacturer: 01/29/2024
• Initial Report FDA Received Date: 01/09/2024
• Supplement Report FDA Received Date: 02/19/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/30/2022
• 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
• Patient Age: 68 YR
• Patient Sex: Male