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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 Problem Detachment of Device or Device Component (2907)
Patient Problem No Code Available (3191)
Event Date 10/15/2019
Event Type  Injury  
Manufacturer Narrative
(b)(6).
 
Event Description
It was reported that a blade detached and was removed by snare. Vascular access intervention therapy (vaivt) was performed on (b)(6) 2019 using a 5. 00mm/2. 0cm/90cm peripheral cutting balloon. On (b)(6) 2019, upon follow-up during echo, a foreign object was noted in the shunt, which seems like a blade of the cutting balloon. The object was then successfully retrieved by snare. No further patient complications were reported.
 
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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 IRELAND LIMITED
ballybrit business park
galway
EI
Manufacturer Contact
jay johnson
two scimed place
maple grove, MN 55311
7634942574
MDR Report Key9353876
MDR Text Key167354057
Report Number2134265-2019-14055
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 Received11/21/2019
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Model Number24630
Device Catalogue Number24630
Device Lot Number0023983063
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer11/13/2019
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received12/12/2019
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured06/20/2019
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: 11/21/2019 Patient Sequence Number: 1
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