MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION CHARGER; CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINAL

Model Number	24682
Medical Device Problem Code	Material Rupture (1546)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	08/16/2018
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that balloon rupture occurred.The 90% stenosed target lesion was located in the mildly tortuous and heavily calcified left superficial femoral artery.A 5.0 x150, 135cm charger balloon catheter was advanced for dilatation.However, during inflation to a nominal pressure, the balloon ruptured.The device was completely removed from the patient's body.A 5.0mmx80mmx135cm (4f) sterling balloon catheter was then advanced for dilatation.However, upon inflation to a nominal pressure, the balloon also ruptured.The device was completely removed from the patient's body and the procedure was completed with a different device.No patient complications were reported and the patient's status was fine.
Event or Problem Description
It was reported that balloon rupture occurred.The 90% stenosed target lesion was located in the mildly tortuous and heavily calcified left superficial femoral artery.A 5.0 x150, 135cm charger balloon catheter was advanced for dilatation.However, during inflation to a nominal pressure, the balloon ruptured.The device was completely removed from the patient's body.A 5.0mmx80mmx135cm (4f) sterling balloon catheter was then advanced for dilatation.However, upon inflation to a nominal pressure, the balloon also ruptured.The device was completely removed from the patient's body and the procedure was completed with a different device.No patient complications were reported and the patient's status was fine.The device was returned 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 balloon longitudinal tear beginning at the distal end of the distal markerband and extending approximately 68mm proximally across the balloon material.An examination of the balloon material and distal markerband identified no issues which could potentially have contributed to this complaint.A visual and microscopic examination identified no issues with the tip which could possibly have contributed to the complaint incident.A visual and tactile examination identified no kinks or damage to the shaft of the device.No other issues were identified during the product analysis.
Event or Problem Description
It was reported that balloon rupture occurred.The 90% stenosed target lesion was located in the mildly tortuous and heavily calcified left superficial femoral artery.A 5.0 x150, 135cm charger balloon catheter was advanced for dilatation.However, during inflation to a nominal pressure, the balloon ruptured.The device was completely removed from the patient's body.A 5.0mmx80mmx135cm (4f) sterling balloon catheter was then advanced for dilatation.However, upon inflation to a nominal pressure, the balloon also ruptured.The device was completely removed from the patient's body and the procedure was completed with a different device.No patient complications were reported and the patient's status was fine.The device was returned 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 balloon longitudinal tear beginning at the distal end of the distal markerband and extending approximately 68mm proximally across the balloon material.An examination of the balloon material and distal markerband identified no issues which could potentially have contributed to this complaint.A visual and microscopic examination identified no issues with the tip which could possibly have contributed to the complaint incident.A visual and tactile examination identified no kinks or damage to the shaft of the device.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: 7860010
• Report Number: 2134265-2018-60882
• Device Sequence Number: 19329468
• Product Code: FGE
• UDI-Device Identifier: 08714729804185
• UDI-Public: 08714729804185
• Combination Product (Y/N): N
• Initial Reporter State: GA
• Initial Reporter Country: US
• PMA/510(K) Number: K112697
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 10/11/2018

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: 04/24/2021
• Device Model Number: 24682
• Device Catalogue Number: 24682
• Device Lot Number: 0022038035
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/04/2018
• Initial Date Received by Manufacturer: 08/17/2018
• Supplement Date Received by Manufacturer: 09/24/2018
• Initial Report FDA Received Date: 09/10/2018
• Supplement Report FDA Received Date: 10/11/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 55 YR