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	06/19/2022
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that balloon rupture occurred.The target lesion was located in the iliac vein.A 10.0 x80, 75cm charger balloon was advanced for dilatation.However, the balloon ruptured during inflation at 10 atmospheres.The procedure was completed with another of the same device.No patient complications were reported and the patient's status was stable.
Event or Problem Description
It was reported that balloon rupture occurred.The target lesion was located in the iliac vein.A 10.0 x80, 75cm charger balloon was advanced for dilatation.However, the balloon ruptured during inflation at 10 atmospheres.The procedure was completed with another of the same device.No patient complications were reported and the patient's status was stable.It was further reported that the balloon ruptured on initial inflation for a few seconds.
Additional Manufacturer Narrative
Updated b5: describe event or problem.
Additional Manufacturer Narrative
Device evaluated by mfr: charger 10.0 x80, 75cm, 14atm was received for analysis.A visual examination identified that the balloon was not folded which indicates that the device was subjected to positive pressure.A balloon longitudinal tear was identified beginning approximately 1mm proximal of the distal markerband and extending approximately 4mm proximally across the balloon material.An examination of the balloon material and markerbands identified no issues which could potentially have contributed to this complaint.The rated burst pressure for this device is 14 atmospheres as per charger specification.A visual examination of the markerbands identified no issues which may potentially have contributed to the complaint incident.A visual and tactile examination identified no kinks or damage to the shaft which may have potentially contributed to the complaint incident.A visual examination identified no damage to the tip.
Event or Problem Description
It was reported that balloon rupture occurred.The target lesion was located in the iliac vein.A 10.0 x80, 75cm charger balloon was advanced for dilatation.However, the balloon ruptured during inflation at 10 atmospheres.The procedure was completed with another of the same device.No patient complications were reported and the patient's status was stable.It was further reported that the balloon ruptured on initial inflation for a few seconds.

• 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; ballybrit business park; galway ; EI
• Manufacturer Contact: jay johnson ; 4100 hamline ave n; arden hills, MN 55112 ; 6515810888
• MDR Report Key: 14943797
• Report Number: 2124215-2022-24437
• Device Sequence Number: 14576284
• Product Code: FGE
• UDI-Device Identifier: 08714729803812
• UDI-Public: 08714729803812
• 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): 08/18/2022

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: 12/10/2023
• Device Model Number: 24681
• Device Catalogue Number: 24681
• Device Lot Number: 0026496885
• 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: 06/28/2022
• Supplement Date Received by Manufacturer: 07/04/2022; 08/16/2022
• Initial Report FDA Received Date: 07/07/2022
• Supplement Report FDA Received Date: 07/12/2022; 08/18/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/10/2020
• 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