MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION XXL ESOPHAGEAL; DILATOR, ESOPHAGEAL

Model Number	23375
Medical Device Problem Code	Material Rupture (1546)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	08/02/2018
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that balloon rupture occurred.The 95% stenosed target lesion was located in the mildly tortuous and chronic thrumbos calcified right subclavian vein and braqueocefalic trunk.After deployment of a wallstent, a 18-4/5.8/120mm xxl esophageal balloon catheter was advanced for post-dilation.During inflation at 5 atmospheres for 1 minute, the pressure descended to 0 atmospheres and it was noted that blood was present in the inflation device.The device was completely removed by simply moving back from the patient's body and it was confirmed that the balloon ruptured.The procedure was completed with another of the same device.No patient complications were reported and the patient's status was stable.
Event or Problem Description
It was reported that balloon rupture occurred.The 95% stenosed target lesion was located in the mildly tortuous and chronic thrumbos calcified right subclavian vein and braqueocefalic trunk.After deployment of a wallstent, a 18-4/5.8/120mm xxl esophageal balloon catheter was advanced for post-dilation.During inflation at 5 atmospheres for 1 minute, the pressure descended to 0 atmospheres and it was noted that blood was present in the inflation device.The device was completely removed by simply moving back from the patient's body and it was confirmed that the balloon ruptured.The procedure was completed with another of the same device.No patient complications were reported and the patient status was stable.The device was returned for analysis.The balloon was unfolded which indicates it had been subjected to positive pressure.Blood was noted within the balloon material which is evidence of a device leak.The investigator retracted the balloon protector in order to inflated the balloon.The returned device was attached to an encore inflation unit and positive pressure was applied when liquid was identified leaking from a longitudinal tear in the balloon material.The tear was noted to begin approximately 3mm proximal to the proximal edge of the distal markerband and extended distally across the balloon material for approximately 8mm.A visual and microscopic examination of the balloon material and markerband identified no issues that have contributed to the complaint incident.The rate of burst pressure of this xxl device is 5atm (atmospheres).No damage or any issues were noted with the shaft of the device.A visual and microscopic examination of the device identified no damage or any issues with the markerbands or tip that could have contributed to the complaint incident.No other issues were identified during the product analysis.
Event or Problem Description
It was reported that balloon rupture occurred.The 95% stenosed target lesion was located in the mildly tortuous and chronic thrumbos calcified right subclavian vein and braqueocefalic trunk.After deployment of a wallstent, a 18-4/5.8/120mm xxl esophageal balloon catheter was advanced for post-dilation.During inflation at 5 atmospheres for 1 minute, the pressure descended to 0 atmospheres and it was noted that blood was present in the inflation device.The device was completely removed by simply moving back from the patient's body and it was confirmed that the balloon ruptured.The procedure was completed with another of the same device.No patient complications were reported and the patient status was stable.The device was returned for analysis.The balloon was unfolded which indicates it had been subjected to positive pressure.Blood was noted within the balloon material which is evidence of a device leak.The investigator retracted the balloon protector in order to inflated the balloon.The returned device was attached to an encore inflation unit and positive pressure was applied when liquid was identified leaking from a longitudinal tear in the balloon material.The tear was noted to begin approximately 3mm proximal to the proximal edge of the distal markerband and extended distally across the balloon material for approximately 8mm.A visual and microscopic examination of the balloon material and markerband identified no issues that have contributed to the complaint incident.The rate of burst pressure of this xxl device is 5atm (atmospheres).No damage or any issues were noted with the shaft of the device.A visual and microscopic examination of the device identified no damage or any issues with the markerbands or tip that could have contributed to the complaint incident.No other issues were identified during the product analysis.

• Brand Name: XXL ESOPHAGEAL
• Common Device Name: DILATOR, ESOPHAGEAL
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; two scimed place; maple grove MN 55311
• MDR Report Key: 7824319
• Report Number: 2134265-2018-60427
• Device Sequence Number: 13846480
• Product Code: KNQ
• UDI-Device Identifier: 08714729163176
• UDI-Public: 08714729163176
• Combination Product (Y/N): N
• Initial Reporter Country: MX
• 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): 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: 08/08/2019
• Device Model Number: 23375
• Device Catalogue Number: 23375
• Device Lot Number: 0019566388
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/03/2018
• Initial Date Received by Manufacturer: 08/02/2018
• Supplement Date Received by Manufacturer: 09/18/2018
• Initial Report FDA Received Date: 08/28/2018
• 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: 63 YR
• Patient Weight: 100