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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 Material Rupture (1546); Detachment of Device or Device Component (2907); Physical Resistance/Sticking (4012)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 11/01/2019
Event Type  Injury  
Manufacturer Narrative
Weight: (b)(6) kg. Initial reporter state: (b)(6).
 
Event Description
It was reported that a balloon rupture and blade detachment occurred. The 90% stenosed target lesion was mildly tortuous and mildly calcified. A 7f introducer sheath was advanced then a. 035 inch guidewire. A 2cm peripheral cutting balloon was selected for use. When inflation was performed, the balloon ruptured at 0atm for 1 second on 1st inflation. The ruptured balloon was removed with slight resistance back into the sheath. Then another 2cm peripheral cutting balloon was unpacked and dilatation was performed without issue. When the ruptured balloon was checked outside the patient's body, only 3 of the 4 blades were visible. Therefore, ivus was performed with opticross18, but no blade was found inside the body. No adverse effect occurred with the patient. The patient condition after the procedure is good.
 
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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 Key9350264
MDR Text Key167378374
Report Number2134265-2019-14208
Device Sequence Number1
Product Code LIT
Combination Product (y/n)N
Reporter Country CodeJA
PMA/PMN Number
K070951
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 01/02/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received11/20/2019
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date04/19/2020
Device Model Number24628
Device Catalogue Number24628
Device Lot Number0022017513
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer11/26/2019
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received12/19/2019
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured04/20/2018
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: 11/20/2019 Patient Sequence Number: 1
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