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

Model Number	23375
Medical Device Problem Codes	Difficult to Remove (1528); Material Rupture (1546)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	09/12/2018
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that balloon rupture occurred and removal difficulties were encountered.The target lesions were located in the inferior vena cava (ivc) and iliac veins.Following stenting, post-dilatation was performed with a 14-4/5.8/120 xxl vascular balloon catheter.During withdrawal, the balloon was blocked at the entry of the 9f introducer sheath.It was noted that the balloon had ruptured and was separated from the catheter distal marker.The balloon remains blocked the right internal jugular vein.An open approach was not effective in retrieving the balloon material safely from the puncture site; an endovascular snaring from the brachial vein access was attempted but it caused migration of the balloon material into the branches of the pulmonary artery.The balloon remains were retrieved by endovascular means from the pulmonary artery to the brachial vein and the right brachial vein was excised by phlebotomy to complete the procedure.The patient was hospitalized three days for observation.No further patient complications were reported and the patient's status was stable.
Event or Problem Description
It was reported that balloon rupture occurred and removal difficulties were encountered.The target lesions were located in the inferior vena cava (ivc) and iliac veins.Following stenting, postdilitation was performed with a 14-4/5.8/120 xxl vascular balloon catheter.During withdrawal, the balloon was blocked at the entry of the 9f introducer sheath.It was noted that the balloon had ruptured and was separated from the catheter distal marker.The balloon remains blocked the right internal jugular vein.An open approach was not effective in retrieving the balloon material safely from the puncture site; an endovascular snaring from the brachial vein access was attempted but it caused migration of the balloon material into the branches of the pulmonary artery.The balloon remains were retrieved by endovascular means from the pulmonary artery to the brachial vein and the right brachial vein was excised by phlebotomy to complete the procedure.The patient was hospitalized three days for observation.No further patient complications were reported and the patient's status was stable.The device was returned for analysis.The xxl device was visually and microscopically examined.The device was received in three separate section.One section consisted of hub/manifold and shaft, the second section of shaft, proximal balloon bond and the proximal markerband and the third section of balloon material, shaft, distal markerband and tip.The balloon was unfolded which indicates it had been subjected to positive pressure.The balloon was detached from the delivery system.A complete circumferential tear was identified in the balloon material at the location of the proximal balloon bond.The balloon material was severely bunched up and the tip was retracted into the bunched up balloon material.Solidified blood was noted on the inside and the outside of the balloon material.A visual and microscopic examination of the balloon material identified no issues that have contributed to the damage identified.A visual and tactile examination identified 2 complete break in the shaft of the device.The first break was identified approximately 573mm distal to the strain relief, this break was consistent with dissection of the shaft.The second shaft break was identified approximately 55mm distal to the distal edge of the proximal markerband.Stretching damage was also noted on the shaft of the device.This damage is consistent with excessive force being applied to the delivery system.No issues were noted with the shaft that could have contributed to the shaft damage.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 VASCULAR
• Common Device Name: DILATOR, ESOPHAGEAL
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; two scimed place; maple grove MN 55311
• MDR Report Key: 7953641
• Report Number: 2134265-2018-61692
• Device Sequence Number: 428425
• Product Code: LIT
• UDI-Device Identifier: 08714729190479
• UDI-Public: 08714729190479
• Combination Product (Y/N): N
• Initial Reporter Country: PL
• PMA/510(K) Number: K150303
• 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): 11/19/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 04/12/2021
• Device Model Number: 23375
• Device Catalogue Number: 23375
• Device Lot Number: 0021986018
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/11/2018
• Initial Date Received by Manufacturer: 09/14/2018
• Supplement Date Received by Manufacturer: 10/26/2018
• Initial Report FDA Received Date: 10/10/2018
• Supplement Report FDA Received Date: 11/19/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 39 YR
• Patient Weight: 80