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	11/11/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(6).
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 same device.There were no patient complications reported and the patient status was stable.
Additional Manufacturer Narrative
Initial reporter facility name: (b)(6) hospital.
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 same device.There were no patient complications reported and the patient status was stable.It was further reported that the lesion was severely stenosed and the balloon ruptured after being inflated once for few seconds.
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 same device.There were no patient complications reported and the patient status was stable.It was further reported that the lesion was severely stenosed and the balloon ruptured after being inflated once for few seconds.
Additional Manufacturer Narrative
E1.Initial reporter facility name: (b)(6).Device evaluated by mfr: charger 12.0 x80, 75cm 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 visual examination identified a balloon longitudinal tear beginning approximately 13mm distal of the proximal markerband and extending approximately 80mm distally 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 12 atmospheres as per charger specification.A visual and microscopic 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 and tactile examination identified no damage to the tip.This concludes the product analysis.

• 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 ; two scimed place; maple grove, MN 55311 ; 7634942574
• MDR Report Key: 12901492
• Report Number: 2134265-2021-15076
• Device Sequence Number: 17149919
• 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): 01/07/2022

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: 03/18/2024
• Device Model Number: 24681
• Device Catalogue Number: 24681
• Device Lot Number: 0026996575
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/14/2021
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 11/23/2021
• Supplement Date Received by Manufacturer: 12/01/2021; 12/21/2021
• Initial Report FDA Received Date: 11/30/2021
• Supplement Report FDA Received Date: 12/08/2021; 01/07/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/19/2021
• 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: 56 YR
• Patient Sex: Male