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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 Material Rupture (1546); Detachment of Device or Device Component (2907)
Patient Problems No Known Impact Or Consequence To Patient (2692); No Code Available (3191)
Event Date 08/01/2020
Event Type  Injury  
Manufacturer Narrative
Date of event: used the first day of the month of the bsc aware date. Event date not provided.
 
Event Description
It was reported that balloon rupture and tip detachment occurred. The target lesion was located in the cephalic arch. A 12-4/5. 8/75 xxl vascular balloon catheter was advanced for dilatation. The balloon was inflated, deflated, and was pulled down to the mid fistula. However, upon trying to inflate the balloon again, the pressure would not increase and upon pulling back the syringe, blood was noticed which indicated that the balloon had ruptured. The device was pulled out from the sheath and entire device aside from the tip was not visible. The tip lodged in an aneurysm that was successfully retrieved by making an incision and pulling it out using a curved forceps. No further patient complications were reported.
 
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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 Key10514892
MDR Text Key206335865
Report Number2134265-2020-11817
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 10/14/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received09/10/2020
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Model Number23375
Device Catalogue Number23375
Device Lot Number0024945141
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer09/03/2020
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received09/25/2020
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured12/17/2019
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: 09/10/2020 Patient Sequence Number: 1
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