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

Model Number 23375

Device Problem Detachment of Device or Device Component (2907)

Patient Problems Perforation (2001); Atrial Perforation (2511); Device Embedded In Tissue or Plaque (3165); No Code Available (3191)

Event Date 09/18/2019

Event Type  Injury  

Event Description

It was reported that balloon detachment occurred. A 10 fr sheath was used in the right internal jugular. The target lesion was located in the iliac vein. A 14-6/5. 8/75 xxl vascular balloon catheter was advanced for post dilatation of a stent. They inflated the balloon and upon removal, the entire balloon detached from the shaft in the inferior vena cava (ivc). The patient was sent to surgery at different location and the device piece was removed during open heart surgery. The patient is recovering normally.

• 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: 9172154
• MDR Text Key: 161709760
• Report Number: 2134265-2019-12211
• Device Sequence Number: 1
• Product Code: LIT
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K150303
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health

Reporter Occupation

• Type of Report: Initial,Followup,Followup
• Report Date: 12/12/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/09/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes

Device Operator

• Device Expiration Date: 05/16/2022
• Device Model Number: 23375
• Device Catalogue Number: 23375
• Device Lot Number: 0023811617
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/23/2019
• Is the Reporter a Health Professional?: Yes

Was the Report Sent to FDA?

• Event Location: No Information
• Date Manufacturer Received: 11/25/2019
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/17/2019
• 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: 10/09/2019 Patient Sequence Number: 1