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

Model Number 23375

Device Problems Difficult to Remove (1528); Detachment of Device or Device Component (2907)

Patient Problem No Code Available (3191)

Event Date 07/16/2020

Event Type  Injury  

Event Description

It was reported that balloon tip detachment and removal difficulties were encountered. The 100% stenosed target lesion was located in the mildly tortuous iliac vein. After a 10fr sheath was placed and a. 035 inch amplatz super stiff gudiewire crossed the lesion, a 14-6/5. 8/75 xxl balloon catheter was advanced for pre-dilatation and successfully deflated. The physician felt resistance as the device was exiting out of the sheath. When the balloon catheter was removed, it was noted that about 4-5cm was sheared off the distal tip of the balloon. A gooseneck snare was used to retrieve the detached component. Angiojet was performed with placement of ekos device and the procedure was completed. No patient complications were reported and the patient did fine.

• 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: 10387308
• MDR Text Key: 202349066
• Report Number: 2134265-2020-09979
• 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
• Report Date: 09/22/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/10/2020
• 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: 0024325619
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/11/2020
• Is the Reporter a Health Professional?: Yes

Was the Report Sent to FDA?

• Event Location: No Information
• Date Manufacturer Received: 08/27/2020
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/26/2019
• 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: 08/10/2020 Patient Sequence Number: 1