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 Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/30/2023
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that balloon rupture occurred.The patient was being treated for may thurner syndrome.The 61% stenosed target lesion was located in the mildly tortuous and severely calcified inferior vena cava through common iliac vein.Following implantation of bilateral 18x90 wallstents, two of 18-4/5.8/75 xxl esophageal balloon catheters were advanced for post-dilatation at the proximal end of stents for kissing balloon inflation with markers just below the end of stents as per angiogram.The balloons were inflated simultaneously; however, one of the balloons burst during the initial inflation at 5 atmospheres (atm) for 2 seconds.The balloon was removed intact and replaced with another of same device.Multiple kissing balloon inflations were performed from the proximal to the distal end of stents at 5 atm.The procedure was completed successfully.No patient complications were reported.
Additional Manufacturer Narrative
Device evaluated by mfr.: a xxl was received for analysis.A visual examination identified that the balloon was not folded which indicates that the balloon was subjected to positive pressure.Blood present in balloon which is indicative of a leak.The balloon was attached to an encore inflation device, subjected to positive pressure and di water was observed to be leaking from a balloon pinhole located approximately 5mm distal from the distal markerband.The rated burst pressure for this device is 8 atmospheres.A visual and tactile examination identified no kinks or damage to the shaft.A visual examination identified no issues with the tip of the device that could have contributed to the complaint incident.
Event or Problem Description
It was reported that balloon rupture occurred.The patient was being treated for may thurner syndrome.The 61% stenosed target lesion was located in the mildly tortuous and severely calcified inferior vena cava through common iliac vein.Following implantation of bilateral 18x90 wallstents, two of 18-4/5.8/75 xxl esophageal balloon catheters were advanced for post-dilatation at the proximal end of stents for kissing balloon inflation with markers just below the end of stents as per angiogram.The balloons were inflated simultaneously; however, one of the balloons burst during the initial inflation at 5 atmospheres (atm) for 2 seconds.The balloon was removed intact and replaced with another of same device.Multiple kissing balloon inflations were performed from the proximal to the distal end of stents at 5 atm.The procedure was completed successfully.No patient complications were reported.

• Brand Name: XXL ESOPHAGEAL
• Common Device Name: DILATOR, ESOPHAGEAL
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 300 boston scientific way; marlborough MA 01752
• Manufacturer (Section G): BOSTON SCIENTIFIC CORPORATION; ballybrit business park; galway ; EI
• Manufacturer Contact: rachel shields ; 4100 hamline ave n; arden hills, MN 55112 ; 6512422111
• MDR Report Key: 17680789
• Report Number: 2124215-2023-47901
• Device Sequence Number: 6351041
• Product Code: KNQ
• UDI-Device Identifier: 08714729163169
• UDI-Public: 08714729163169
• Combination Product (Y/N): N
• Initial Reporter State: MI
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 09/20/2023

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: 03/12/2026
• Device Model Number: 23375
• Device Catalogue Number: 23375
• Device Lot Number: 0031218259
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 08/30/2023
• Supplement Date Received by Manufacturer: 09/14/2023
• Initial Report FDA Received Date: 09/05/2023
• Supplement Report FDA Received Date: 09/20/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/13/2023
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown