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	04/22/2022
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that balloon rupture occurred.The stenosed target lesion was located in the iliac vein.A 12.0 x80, 75cm charger balloon catheter was advanced for dilatation.However, during inflation at 10 atmospheres, the balloon ruptured.The procedure was completed with another of the same device.There were no patient complications reported and the patient status was stable.
Additional Manufacturer Narrative
Updated b5: describe event or problem.
Event or Problem Description
It was reported that balloon rupture occurred.The stenosed target lesion was located in the iliac vein.A 12.0 x80, 75cm charger balloon catheter was advanced for dilatation.However, during inflation at 10 atmospheres, the balloon ruptured.The procedure was completed with another of the same device.There were no patient complications reported and the patient status was stable.It was further reported that the balloon was inflated once for a few seconds before it ruptured.
Event or Problem Description
It was reported that balloon rupture occurred.The stenosed target lesion was located in the iliac vein.A 12.0 x80, 75cm charger balloon catheter was advanced for dilatation.However, during inflation at 10 atmospheres, the balloon ruptured.The procedure was completed with another of the same device.There were no patient complications reported and the patient status was stable.It was further reported that the balloon was inflated once for a few seconds before it ruptured.

• 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: 14283777
• Report Number: 2134265-2022-05178
• Device Sequence Number: 6256272
• 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
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 07/25/2022

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: 10/28/2024
• Device Model Number: 24681
• Device Catalogue Number: 24681
• Device Lot Number: 0028290086
• 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: 04/27/2022
• Supplement Date Received by Manufacturer: 05/06/2022; 07/13/2022
• Initial Report FDA Received Date: 05/04/2022
• Supplement Report FDA Received Date: 05/18/2022; 07/25/2022
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 10/29/2021
• 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: 66 YR
• Patient Sex: Male