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	01/04/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(6).
Event or Problem Description
It was reported that balloon rupture occurred.The target lesion was located iliac vein.A 12.0 x 40, 75cm charger catheter was advanced for dilation.However, during angioplasty at 4 atmospheres for 5 seconds the balloon ruptured.The device was completely removed from the patient body.There were no patient complications nor injuries were reported.
Additional Manufacturer Narrative
Initial reporter address 1 - (b)(6).Device evaluated by manufacturer: the device was returned and the balloon was examined.The examination identified that the balloon was not folded which indicates that the balloon was subjected to positive pressure.Blood was identified within the balloon which is evidence of a device leak.A balloon longitudinal tear was identified beginning approximately 5mm distal of the proximal markerband and extending approximately 38mm distally across the balloon material.An examination of the balloon material and markerbands identified no issues which could potentially have contributed to this complaint.A visual and microscopic examination of the tip identified no issues with the tip which could possibly have contributed to the complaint incident.A visual and tactile examination of the shaft found no kinks or damage along 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 target lesion was located iliac vein.A 12.0 x 40, 75cm charger catheter was advanced for dilation.However, during angioplasty at 4 atmosopheres for 5 seconds the balloon ruptured.The device was completely removed from the patient body.There were no patient complications nor injuries were reported.

• 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: 8257217
• Report Number: 2134265-2019-00117
• Device Sequence Number: 13931964
• Product Code: FGE
• UDI-Device Identifier: 08714729803867
• UDI-Public: 08714729803867
• 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): 03/07/2019

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: 06/07/2019
• Device Model Number: 24681
• Device Catalogue Number: 24681
• Device Lot Number: 0019344497
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/13/2019
• Initial Date Received by Manufacturer: 01/04/2019
• Supplement Date Received by Manufacturer: 02/28/2019
• Initial Report FDA Received Date: 01/17/2019
• Supplement Report FDA Received Date: 03/07/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1