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	01/28/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the balloon burst.The stenosed target lesion was located in the peripheral vascular system.A 7.0 x40, 75cm charger balloon was selected for percutaneous transluminal angioplasty (pta).During the procedure, it was noted that the balloon burst before the bursting pressure was reached.The procedure was completed with a new balloon dilatation catheter.No complications were reported and the patient was stable post-procedure.
Additional Manufacturer Narrative
E1 - initial reporter address 1: (b)(6.
Event or Problem Description
It was reported that the balloon burst.The stenosed target lesion was located in the peripheral vascular system.A 7.0 x40, 75cm charger balloon was selected for percutaneous transluminal angioplasty (pta).During the procedure, it was noted that the balloon burst before the bursting pressure was reached.The procedure was completed with a new balloon dilatation catheter.No complications were reported and the patient was stable post-procedure.It was further reported that the 60% stenosed target lesion was located in the moderately tortuous and moderately calcified peripheral vascular system.Additionally, the balloon ruptured during the first inflation at 16 atmospheres for 5 seconds.The device was removed from the patient's body without any problem using the normal method.
Additional Manufacturer Narrative
E1 - initial reporter address 1: (b)(6).

• 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: 18680315
• Report Number: 2124215-2024-06105
• Device Sequence Number: 12301041
• Product Code: FGE
• UDI-Device Identifier: 08714729804536
• UDI-Public: 08714729804536
• 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
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 03/04/2024

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: 08/19/2025
• Device Model Number: 24681
• Device Catalogue Number: 24681
• Device Lot Number: 0029991213
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 01/31/2024
• Supplement Date Received by Manufacturer: 02/22/2024
• Initial Report FDA Received Date: 02/09/2024
• Supplement Report FDA Received Date: 03/04/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 08/20/2022
• 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