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	03/08/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that balloon rupture occurred.The patient presented with thoracic aortic dissection.The greater than 95% severely stenosed target lesion was located in the greater than 100 degrees angle between the subclavian and the aorta and non-calcified thoracic aorta.An 8.0 x40, 75cm charger balloon catheter was advanced for dilatation.However, during first inflation at 6-7 atmospheres, the balloon ruptured.The device was withdrawn from the patient directly and was replaced with another of the same device, and an 10x40 epic stent was implanted.No complications were reported, and the patient was stable post procedure.
Additional Manufacturer Narrative
Device evaluated by mfr: the device was returned for evaluation.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 8mm proximal of the proximal markerband and extending approximately 56mm distally across the balloon material.The rated burst pressure for this device as per specification 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 during the product analysis.
Event or Problem Description
It was reported that balloon rupture occurred.The patient presented with thoracic aortic dissection.The greater than 95% severely stenosed target lesion was located in the greater than 100 degrees angle between the subclavian and the aorta and non-calcified thoracic aorta.An 8.0 x40, 75cm charger balloon catheter was advanced for dilatation.However, during first inflation at 6-7 atmospheres, the balloon ruptured.The device was withdrawn from the patient directly and was replaced with another of the same device, and an 10x40 epic stent was implanted.No complications were reported, and the patient was stable post procedure.

• 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: 18973107
• Report Number: 2124215-2024-16855
• Device Sequence Number: 6035629
• Product Code: FGE
• UDI-Device Identifier: 08714729804673
• UDI-Public: 08714729804673
• 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): 04/24/2024

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: 07/26/2026
• Device Model Number: 24681
• Device Catalogue Number: 24681
• Device Lot Number: 0032098528
• 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: 03/14/2024
• Supplement Date Received by Manufacturer: 04/16/2024
• Initial Report FDA Received Date: 03/25/2024
• Supplement Report FDA Received Date: 04/24/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/27/2023
• 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: 40 YR
• Patient Sex: Male