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	09/27/2023
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that balloon rupture occurred.The patient presented with may thurner syndrome and underwent venogram.The 80% stenosed target lesion was located in the mildly tortuous and severely calcified common iliac vein (civ) and external iliac vein (eiv).Following bilateral placement of wallstents, two 16-4/5.8/75 xxl esophageal balloon catheters were placed bilaterally at the proximal civ for kissing balloon inflation at 5 atmospheres (atm).The balloons were moved bilaterally to mid to distal (civ).However, during the second inflation at 5 atm for a few seconds, one of the balloons ruptured.The balloon was replaced with another of same device and inflation was completed through to distal eiv.No patient complications were reported.
Additional Manufacturer Narrative
Device evaluated by mfr: a xxl device 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 5mm distal from the distal markerband.An examination of the balloon material and the tip region identified no issues which could potentially have contributed to this complaint.The rated burst pressure for this device is 8 atmospheres as per xxl specification.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.
Event or Problem Description
It was reported that balloon rupture occurred.The patient presented with may thurner syndrome and underwent venogram.The 80% stenosed target lesion was located in the mildly tortuous and severely calcified common iliac vein (civ) and external iliac vein (eiv).Following bilateral placement of wallstents, two 16-4/5.8/75 xxl esophageal balloon catheters were placed bilaterally at the proximal civ for kissing balloon inflation at 5 atmospheres (atm).The balloons were moved bilaterally to mid to distal (civ).However, during the second inflation at 5 atm for a few seconds, one of the balloons ruptured.The balloon was replaced with another of same device and inflation was completed through to distal eiv.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: 17916872
• Report Number: 2124215-2023-56222
• Device Sequence Number: 6653209
• Product Code: KNQ
• UDI-Device Identifier: 08714729163060
• UDI-Public: 08714729163060
• 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): 10/25/2023

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: 07/18/2026
• Device Model Number: 23375
• Device Catalogue Number: 23375
• Device Lot Number: 0032045087
• 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: 09/27/2023
• Supplement Date Received by Manufacturer: 10/23/2023
• Initial Report FDA Received Date: 10/11/2023
• Supplement Report FDA Received Date: 10/25/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/19/2023
• 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