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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 24628
Device Problems Leak/Splash (1354); Material Rupture (1546)
Patient Problems Extravasation (1842); No Consequences Or Impact To Patient (2199)
Event Date 03/23/2020
Event Type  Injury  
Manufacturer Narrative
(b)(6).
 
Event Description
It was reported that a balloon rupture occurred. The 75% stenosed target lesion was located in the moderately tortuous forearm. A 5. 00mm / 2. 0cm / 50cm peripheral cutting balloon was selected for use in a shunt percutaneous transluminal angioplasty. During procedure, at fourth inflation, the balloon ruptured at 3 atm for 90 seconds. However, it was noted that the rupture of the blood vessel was confirmed at the same time as the rupture of the balloon. This device was inflated 4 times and was inflated three times at area different from the area where vascular rupture occurred. Subsequently, the blood vessel ruptured in one dilation and was not sure as to occurred first, rupture of the balloon or the rupture of the blood vessel. However, it was further reported that there was no perforation occurred. Then, the physician tried to stop bleeding from inside the blood vessel with a balloon, but the bleeding could not be stopped, so the physician surgically stopped the bleeding. There were no resistance and abnormalities noted. The procedure was not resolved. No patient complications reported. The patient was stable after the procedure.
 
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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 Key9923594
MDR Text Key186549044
Report Number2134265-2020-04377
Device Sequence Number1
Product Code LIT
Combination Product (y/n)N
Reporter Country CodeJA
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,distri
Reporter Occupation
Type of Report Initial,Followup
Report Date 04/09/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received04/03/2020
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date11/17/2021
Device Model Number24628
Device Catalogue Number24628
Device Lot Number0024784245
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received03/23/2020
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured11/18/2019
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: 04/03/2020 Patient Sequence Number: 1
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