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	08/10/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
E1: initial reporter phone:(b)(6).
Event or Problem Description
It was reported that balloon rupture occurred.A 12.0 x80, 75cm charger balloon catheter was advanced for post dilation after a venous stent implantation.However, it was noted that the balloon was broken.The procedure was completed with another of same device.There were no patient complications reported and the patient was stable.
Event or Problem Description
It was reported that balloon rupture occurred.A 12.0 x80, 75cm charger balloon catheter was advanced for post dilation after a venous stent implantation.However, it was noted that the balloon was broken.The procedure was completed with another of same device.There were no patient complications reported and the patient was stable.It was further reported that the target lesion was 80% stenosed and located in the common iliac vein.The balloon ruptured during the initial inflation at 10 atmospheres for 60 seconds and was removed from the patient.
Additional Manufacturer Narrative
E1 - initial reporter phone: (b)(6).Device evaluated by mfr.: a charger device was received for analysis.A visual examination identified that the balloon was not folded which indicates that the balloon was subjected to positive pressure.A longitudinal tear was identified in the balloon material.The tear measured approximately 50mm in length and extended from a position 7mm proximal of the proximal markerband to 25mm proximal of the distal markerband.A visual examination observed no damage to the tip of the device.A visual and tactile examination of the shaft of the device found no issues.A visual examination found no issues or damage to the markerbands of the device.
Additional Manufacturer Narrative
B5 - describe event or problem: updated to include new information obtained.E1 - initial reporter phone: (b)(6).
Event or Problem Description
It was reported that balloon rupture occurred.A 12.0 x80, 75cm charger balloon catheter was advanced for post dilation after a venous stent implantation.However, it was noted that the balloon was broken.The procedure was completed with another of same device.There were no patient complications reported and the patient was stable.It was further reported that the target lesion was 80% stenosed and located in the common iliac vein.The balloon ruptured during the initial inflation at 10 atmospheres for 60 seconds and was removed from the patient.

• 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: 17561251
• Report Number: 2124215-2023-43888
• Device Sequence Number: 17856089
• 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): 09/11/2023

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: 06/28/2025
• Device Model Number: 24681
• Device Catalogue Number: 24681
• Device Lot Number: 0029675751
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: Not provided
• Supplement Date Received by Manufacturer: 08/18/2023; 09/05/2023
• Initial Report FDA Received Date: 08/16/2023
• Supplement Report FDA Received Date: 08/22/2023; 09/11/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/29/2022
• 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