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

Model Number	23375
Medical Device Problem Codes	Inflation Problem (1310); Material Rupture (1546)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/25/2022
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that balloon rupture occurred.The patient underwent percutaneous coronary intervention (pci).The target lesion was located in the iliac vein.Vascular access was obtained via the left femoral vein and a 10f sheath was inserted.After advancing a 260 cm guidewire to the inferior cavity, a conical artery catheter was exchanged with a stiffened guidewire.A 4-6/5.8/75 xxl vascular balloon catheter was advanced for dilatation.During digital subtraction angiography (dsa), it was found that the rated burst pressure of the balloon was 8 atmospheres.However, during inflation, the pressure could not go higher than 4 atmospheres.Consequently, the balloon was not fully inflated.Upon withdrawal, it was found that the balloon was leaking as the contrast agent had mixed with blood.A syringe was used to inject a liquid into the balloon outside the patient and a pinhole was noted.The device was replaced with a 16x4 xxl vascular balloon catheter and then a 16x90 boston scientific stent was implanted to complete the procedure.No patient complications were reported and the patient status was stable.
Additional Manufacturer Narrative
Device evaluated by mfr: a xxl device was returned for analysis.A visual examination identified that the balloon was not folded which indicates that the balloon was subjected to positive pressure.A longitudinal tear was identified in the balloon material.The tear measured 8mm in length and extended from a position 20mm distal of the proximal markerband to 29mm distal of the proximal markerband.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 which may have potentially contributed to the complaint incident.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 underwent percutaneous coronary intervention (pci).The target lesion was located in the iliac vein.Vascular access was obtained via the left femoral vein and a 10f sheath was inserted.After advancing a 260 cm guidewire to the inferior cavity, a conical artery catheter was exchanged with a stiffened guidewire.A 4-6/5.8/75 xxl vascular balloon catheter was advanced for dilatation.During digital subtraction angiography (dsa), it was found that the rated burst pressure of the balloon was 8 atmospheres.However, during inflation, the pressure could not go higher than 4 atmospheres.Consequently, the balloon was not fully inflated.Upon withdrawal, it was found that the balloon was leaking as the contrast agent had mixed with blood.A syringe was used to inject a liquid into the balloon outside the patient and a pinhole was noted.The device was replaced with a 16x4 xxl vascular balloon catheter and then a 16x90 boston scientific stent was implanted to complete the procedure.No patient complications were reported and the patient status was stable.

• Brand Name: XXL VASCULAR
• Common Device Name: DILATOR, ESOPHAGEAL
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; two scimed place; maple grove MN 55311
• Manufacturer (Section G): BOSTON SCIENTIFIC CORPORATION; ballybrit business park; galway ; EI
• Manufacturer Contact: jay johnson ; 4100 hamline ave n; arden hills, MN 55112 ; 6515810888
• MDR Report Key: 15419172
• Report Number: 2124215-2022-33704
• Device Sequence Number: 12416827
• Product Code: LIT
• UDI-Device Identifier: 08714729190486
• UDI-Public: 08714729190486
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: K150303
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative,Distributor
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 10/07/2022

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: 02/26/2025
• Device Model Number: 23375
• Device Catalogue Number: 23375
• Device Lot Number: 0028949226
• 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: 08/25/2022
• Supplement Date Received by Manufacturer: 09/28/2022
• Initial Report FDA Received Date: 09/14/2022
• Supplement Report FDA Received Date: 10/07/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/27/2022
• 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 Age: 55 YR
• Patient Sex: Male
• Patient Weight: 60 KG