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	05/06/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Age at time of event: over 70 years old.
Event or Problem Description
It was reported that balloon ruptured occured.The target lesion was located in the superficial femoral artery.A 7.0mm x40mm, 135cm charger balloon catheter was advanced for dilation.However, during the procedure after a couple inflations, the balloon burst at nominal pressure between 4 and 6 atmosphere.The device was completely removed over the wire.The procedure completed with another of the same device.No patient complication were reported.
Additional Manufacturer Narrative
Age at time of event: over 70 years old.Device evaluated by mfr.: a visual and microscopic examination of the balloon identified no tears or holes in the balloon material.The balloon was unfolded and there was a build-up of some liquid inside the balloon.Attempts to inflate the balloon failed.As a result the device was soaked in a heated water bath at 37 degrees celsius in an attempt to dissolve any solidified blood or contrast media inside the balloon.All additional attempts to inflate or deflate the balloon failed.As a result the balloon was massaged in order to force the liquid, which was present in the returned balloon, all around different areas of the balloon.During this process no leaks were found in the balloon.A visual and tactile examination of the catheter identified no kinks or damage.Using a blade the shaft was dissected approximately 1cm proximal to the proximal balloon sleeve.When the dissection was made, it was possible to flush liquid through the main section of the device.This confirmed that the blockage was just proximal to the proximal balloon bond.The shaft was cross sectioned at this site and it was confirmed that the inflation lumen was blocked with solidified blood.Although no leak could be confirmed in the balloon, blood inside the inflation lumen is consistent with a system leak in the device.No other issues were noted with this device.
Event or Problem Description
It was reported that balloon ruptured occurred.The target lesion was located in the superficial femoral artery.A 7.0mm x40mm, 135cm charger balloon catheter was advanced for dilation.However, during the procedure after a couple inflations, the balloon burst at nominal pressure between 4 and 6 atmosphere.The device was completely removed over the wire.The procedure completed with another of the same device.No patient complication 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: 8628045
• Report Number: 2134265-2019-05575
• Device Sequence Number: 2207483
• Product Code: FGE
• UDI-Device Identifier: 08714729804529
• UDI-Public: 08714729804529
• Combination Product (Y/N): N
• Initial Reporter State: KS
• 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): 07/08/2019

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: 08/06/2021
• Device Model Number: 24681
• Device Catalogue Number: 24681
• Device Lot Number: 0022478673
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/27/2019
• Initial Date Received by Manufacturer: 05/06/2019
• Supplement Date Received by Manufacturer: 06/24/2019
• Initial Report FDA Received Date: 05/21/2019
• Supplement Report FDA Received Date: 07/08/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1