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	08/22/2018
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that balloon rupture occurred.The target lesion was located in the iliac vein.A 12.0 x80, 75cm charger balloon catheter was advanced at an overlap between two previously implanted 14x90mm wallstents.However, the balloon could not be fully dilated and ruptured.The procedure was completed with another of the same.No complications were reported and patient's status was stable.
Event or Problem Description
It was reported that balloon rupture occurred.The target lesion was located in the iliac vein.A 12.0 x80, 75cm charger balloon catheter was advanced at an overlap between two previously implanted 14x90mm wallstents.However, the balloon could not be fully dilated and ruptured.The procedure was completed with another of the same.No complications were reported and patient's status was stable.Device evaluated by mfr: a visual examination of the returned device confirmed that the balloon was unfolded had been subjected to positive pressure.A visual and microscopic examination was performed on the returned charger device.Blood was noted within the balloon which is evidence of a device leak.The returned device was attached to an encore inflation unit and positive pressure was applied.The balloon could not be inflated due to the presence of solidified blood within the balloon material.The device was soaked in a water bath at a temperature of 37 degrees celsius to help soften the solidified blood before further inflation attempts were made.On removal from the bath the returned device was again attached to encore inflation unit and positive pressure was applied when a pinhole leak was identified in the balloon approximately 52mm distal to the distal edge of the proximal markerband.A visual and microscopic examination identified no issues with the balloon material that could have contributed to the complaint incident.A visual and microscopic examination found no issue with the markerbands of the device which could have contributed to the complaint incident.A visual and tactile examination identified no damage or any issues along the length of the device.No issues were noted with the tip section 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: 7890211
• Report Number: 2134265-2018-61136
• Device Sequence Number: 2726173
• 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,distri
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 10/15/2018

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: 02/07/2021
• Device Model Number: 24681
• Device Catalogue Number: 24681
• Device Lot Number: 0021718331
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/06/2018
• Initial Date Received by Manufacturer: 08/24/2018
• Supplement Date Received by Manufacturer: 09/20/2018
• Initial Report FDA Received Date: 09/19/2018
• Supplement Report FDA Received Date: 10/15/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: STENT: TWO 14X90MM WALLSTENTS; STENT: TWO 14X90MM WALLSTENTS