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U.S. Department of Health and Human Services

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

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BOSTON SCIENTIFIC CORPORATION XXL VASCULAR DILATOR, ESOPHAGEAL Back to Search Results
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.
 
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Brand NameXXL VASCULAR
Type of DeviceDILATOR, 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 Key10387308
MDR Text Key202349066
Report Number2134265-2020-09979
Device Sequence Number1
Product Code LIT
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K150303
Number of Events Reported1
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 Received08/10/2020
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Model Number23375
Device Catalogue Number23375
Device Lot Number0024325619
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer08/11/2020
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received08/27/2020
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured08/26/2019
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
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