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

Model Number	24681
Medical Device Problem Codes	Break (1069); Material Rupture (1546)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/16/2023
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that shaft break occurred.The stenosed target lesion was located in the iliac vein.A 12.0 x80, 75cm charger balloon catheter was advanced for dilation.However, during procedure, the balloon was broken.The procedure was completed with another of the same device.There were no patient complications reported, and the patient condition was stable.
Event or Problem Description
It was reported that shaft break occurred.The stenosed target lesion was located in the iliac vein.A 12.0 x80, 75cm charger balloon catheter was advanced for dilation.However, during procedure, the balloon was broken.The procedure was completed with another of the same device.There were no patient complications reported, and the patient condition was stable.It was further reported that the balloon material itself broke, and not the shaft.The target lesion was 70% stenosed, non-tortuous, and non-calcified.
Additional Manufacturer Narrative
B5 - describe event or problem: updated to include new information obtained.H6 - device codes: updated from break to material rupture.
Additional Manufacturer Narrative
D4: lot number: updated from 0029642574 to 29458309.Device evaluated by mfr.: a charger device 14 atmospheres was received for analysis.As per the charger directions for use the catheter is compatible with a 0.035-inch (0.89 mm) guidewire.The investigator successfully loaded a boston scientific 0.035in guidewire through the charger device and removed it with no resistance encountered.No issues were identified with the device that could potentially have contributed to the complaint incident.The guidewire used by the customer was not returned for analysis.A visual and tactile examination identified that the balloon was not tightly folded and had been subjected to positive pressure.Blood note inside the balloon is evidence of a device leak.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 2mm proximal from the proximal markerband.A visual and tactile examination identified no issues with the shaft of the device.A visual examination found no issues with the markerbands or tip of the device.
Event or Problem Description
It was reported that shaft break occurred.The stenosed target lesion was located in the iliac vein.A 12.0 x80, 75cm charger balloon catheter was advanced for dilation.However, during procedure, the balloon was broken.The procedure was completed with another of the same device.There were no patient complications reported, and the patient condition was stable.It was further reported that the balloon material itself broke, and not the shaft.The target lesion was 70% stenosed, non-tortuous, and non-calcified.

• 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: jeff wallner ; 4100 hamline ave n; arden hills, MN 55112 ; 6515811560
• MDR Report Key: 16661064
• Report Number: 2124215-2023-15375
• Device Sequence Number: 20484714
• Product Code: FGE
• UDI-Device Identifier: 08714729803881
• UDI-Public: 08714729803881
• 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: Foreign,Health Professional,Company Representative,Distributor
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 05/17/2023

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: 05/23/2025
• Device Model Number: 24681
• Device Catalogue Number: 24681
• Device Lot Number: 0029458309
• 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: 03/21/2023
• Supplement Date Received by Manufacturer: 03/31/2023; 05/09/2023
• Initial Report FDA Received Date: 04/02/2023
• Supplement Report FDA Received Date: 04/06/2023; 05/17/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/24/2022
• 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: 70 YR
• Patient Sex: Female