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	12/27/2022
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that balloon rupture occurred.The 70% stenosed target lesion was located in a moderately tortuous and moderately calcified fistula.A 7.0 x60, 75cm charger balloon catheter was advanced for dilatation.Burst atmospheric pressure was 18.However, during the third inflation at 14 atmospheres, the balloon bursts.The device was removed intact and the procedure was completed with another balloon catheter.There were no patient complications reported.
Event or Problem Description
It was reported that balloon rupture occurred.The 70% stenosed target lesion was located in a moderately tortuous and moderately calcified fistula.A 7.0 x60, 75cm charger balloon catheter was advanced for dilatation.Burst atmospheric pressure was 18.However, during the third inflation at 14 atmospheres, the balloon bursts.The device was removed intact and the procedure was completed with another balloon catheter.There were no patient complications reported.It was further reported that the target lesion was located in a mildly tortuous and moderately calcified vein anastomoses.As per technician, there were nothing noted on the balloon, and it was intact when removed.

• Brand Name: CHARGER
• Common Device Name: CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINAL
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; two scimed place; maple grove MN 55311
• Manufacturer (Section G): BOSTON SCIENTIFIC CORPORATION; pmt 741 persiaran cassia selat; bandarcassia, pulau pinan 14110 ; MY 14110
• Manufacturer Contact: jay johnson ; 4100 hamline ave n; arden hills, MN 55112 ; 6515810888
• MDR Report Key: 16321681
• Report Number: 2124215-2023-05301
• Device Sequence Number: 18288464
• Product Code: FGE
• UDI-Device Identifier: 08714729804543
• UDI-Public: 08714729804543
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• 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: Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 03/08/2023

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: 08/02/2025
• Device Model Number: 24681
• Device Catalogue Number: 24681
• Device Lot Number: 0029880970
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 01/30/2023
• Supplement Date Received by Manufacturer: 03/02/2023
• Initial Report FDA Received Date: 02/08/2023
• Supplement Report FDA Received Date: 03/08/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 08/03/2022
• 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 Sex: Unknown