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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION 2CM PERIPHERAL CUTTING BALLOON CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINA

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BOSTON SCIENTIFIC CORPORATION 2CM PERIPHERAL CUTTING BALLOON CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINA Back to Search Results
Model Number 24630
Device Problems Deflation Problem (1149); Difficult to Remove (1528); Material Integrity Problem (2978)
Patient Problem Hemorrhage/Bleeding (1888)
Event Date 03/18/2021
Event Type  Injury  
Event Description
It was reported that the balloon would not deflate and was manually burst in order to remove the device from the patient. An 8mm, 2cm peripheral cutting balloon was selected for use in an upper arm fistuloplasty procedure. During the procedure, two structures were successfully treated with the balloon. After the last inflation, the balloon would not fully deflate. Contrast was seen in the balloon. The balloon was partially inflated again to see if it would deflate. An empty 20ml syringe was used to pull back negative pressure, but this did not empty all the contrast. The balloon was punctured with a needle through the flesh in order to deflate and remove the balloon from the patient. This was partially successful, but there was still contrast in the balloon. Repeated attempts were made to pull the partially deflated balloon back into the 7f 11cm super sheath, but these attempts failed. The physician believes this caused damage to the shaft of the balloon which could be seen upon removal. The sheath and the partially inflated balloon were removed together, which involved dragging the balloon and sheath out together. This resulted in a ragged exit hole in the upper arm that required stitches followed by 10 minutes of pushing to achieve stasis. After this and while still in recovery, the exit wound opened, and the patient bled out approximately 250mls of blood. A further 30 minutes of pressure was applied to the exit wound, and this stopped the flow of blood. Due to these events, the patient was admitted to a ward bed for observation and is to be reviewed by surgeons. The patient has not yet had surgery but may need reconstructive fistula surgery.
 
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Brand Name2CM PERIPHERAL CUTTING BALLOON
Type of DeviceCATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINA
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 Key11561833
MDR Text Key241999425
Report Number2134265-2021-03783
Device Sequence Number1
Product Code LIT
Combination Product (y/n)N
Reporter Country CodeUK
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Reporter Occupation
Type of Report Initial,Followup,Followup,Followup
Report Date 09/12/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received03/24/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Model Number24630
Device Catalogue Number24630
Device Lot Number0026527485
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer03/31/2021
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received08/20/2021
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured12/16/2020
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: 03/24/2021 Patient Sequence Number: 1
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