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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 Problem Inflation Problem (1310)
Patient Problems Hemorrhage/Bleeding (1888); Thrombosis (2100); Stenosis (2263)
Event Date 07/21/2020
Event Type  Injury  
Event Description
It was reported that bleeding and vessel damage occurred. The 99% stenosed target lesion area was located in a mildly tortuous and mildly calcified forearm vein. A 5. 00mm / 2. 0cm / 50cm peripheral cutting balloon (pcb) and bravus balloon dilatation catheter were selected for vascular access intervention therapy. During the procedure, the bravus balloon dilatation catheter had balloon inflation failure. The peripheral cutting balloon was used and also had inflation failure. Inflation failure and bleeding was confirmed when the pcb was inflated at 10 atm. The amount of bleeding was unknown, the physician noted that the bleeding was likely vessel damage. The bleeding was arrested by pcb inflation at 2 atm. The procedure was completed after hemostasis was confirmed with a different device. On july 28th, occlusion was seen. Although hemostasis was performed, thrombus was in place on where the balloon was inflated. The patient was scheduled for an intervention.
 
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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 Key10385865
MDR Text Key202253574
Report Number2134265-2020-10723
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,foreig
Reporter Occupation
Type of Report Initial
Report Date 08/10/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received08/10/2020
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Model Number24628
Device Catalogue Number24628
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 Received07/21/2020
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
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: 08/10/2020 Patient Sequence Number: 1
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