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

Model Number 23375

Device Problems Material Rupture (1546); Device-Device Incompatibility (2919)

Patient Problem No Code Available (3191)

Event Date 08/24/2020

Event Type  Injury  

Event Description

It was reported that balloon rupture occurred and additional intervention was required. A ct angiography was performed revealing an iliac occlusion with a permeable femoral vein, as well as compression of the left primary iliac vein. A 14-6/5. 8/75 xxl balloon and a wallstent stent were advanced to the target lesion, but a balloon burst occurred. It was noted that a piece of the balloon remained on the stent. The balloon piece remaining inside the patient was retrieved by surgical approach. The procedure was successfully completed. No further patient complications were reported in relation to this event and the patient was reported to be fully recovered following the procedure.

• Brand Name: XXL VASCULAR
• Type of Device: 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 ; two scimed place; maple grove, MN 55311 ; 7634942574
• MDR Report Key: 10555347
• MDR Text Key: 207585478
• Report Number: 2134265-2020-12979
• Device Sequence Number: 1
• Product Code: LIT
• Combination Product (y/n): N
• Reporter Country Code: FR
• PMA/PMN Number: K150303
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig

Reporter Occupation

• Type of Report: Initial
• Report Date: 09/18/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/18/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes

Device Operator

• Device Model Number: 23375
• Device Catalogue Number: 23375
• Device Lot Number: 0025029154
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes

Was the Report Sent to FDA?

• Event Location: No Information
• Date Manufacturer Received: 08/25/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/13/2020
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial

Patient Treatment Data

Date Received: 09/18/2020 Patient Sequence Number: 1