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 Consequences Or Impact To Patient (2199)
Date of Event	02/21/2020
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that balloon rupture occurred.Vascular access was obtained via the left iliofemoral vein through the left anterior tibial vein.The 95% stenosed target lesion was located in the iliac vein.A 12.0 x80, 75cm charger balloon was advanced for dilatation.However, during inflation at 8 atmospheres, the balloon ruptured.There was blood flowed back into the pressure pump.The device was removed and the procedure was completed with another of the same device.No patient complications were reported.
Event or Problem Description
It was reported that balloon rupture occurred.Vascular access was obtained via the left iliofemoral vein through the left anterior tibial vein.The 95% stenosed target lesion was located in the iliac vein.A 12.0 x80, 75cm charger balloon was advanced for dilatation.However, during inflation at 8 atmospheres, the balloon ruptured.There was blood flowed back into the pressure pump.The device was removed and the procedure was completed wih another of the same device.No patient complications were reported.
Additional Manufacturer Narrative
Device evaluated by mfr: charger device - (b)(6), was received for analysis.A visual examination identified that the balloon was not folded which indicates that the balloon was subjected to positive pressure.Blood was identified within the balloon and inflation lumen which is evidence of a device leak.A visual and microscopic examination identified a longitudinal tear in the balloon material beginning approximately 3mm proximal of the distal markerband and extending approximately 11mm 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 12 atmospheres.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 which may have potentially contributed to the complaint incident.No other issues were identified during 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
• MDR Report Key: 9914934
• Report Number: 2134265-2020-04292
• Device Sequence Number: 2742078
• 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
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 05/01/2020

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: 10/14/2022
• Device Model Number: 24681
• Device Catalogue Number: 24681
• Device Lot Number: 0024596956
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/09/2020
• Initial Date Received by Manufacturer: 03/20/2020
• Supplement Date Received by Manufacturer: 04/29/2020
• Initial Report FDA Received Date: 04/02/2020
• Supplement Report FDA Received Date: 05/01/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 54 YR