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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 Device Dislodged or Dislocated (2923)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 08/22/2018
Event Type  malfunction  
Event Description
It was reported that blade lifted occurred. The target lesion was located in the shunt. An 8. 00mmx2. 0cmx50cm peripheral cutting balloon was used for percutaneous transluminal angioplasty. During withdrawal, it was noted that the blade came partially off from balloon after it was pulled back from the sheath. The procedure was completed with this device. No patient complications were reported.
 
Event Description
It was reported that blade lifted occurred. The target lesion was located in the shunt. An 8. 00mmx2. 0cmx50cm peripheral cutting balloon was used for percutaneous transluminal angioplasty. During withdrawal, it was noted that the blade came partially off from balloon after it was pulled back from the sheath. The procedure was completed with this device. No patient complications were reported. It was further reported the patient is doing well.
 
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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
MDR Report Key7883265
MDR Text Key120526788
Report Number2134265-2018-61091
Device Sequence Number1
Product Code LIT
Combination Product (y/n)N
PMA/PMN Number
K070951
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,distri
Type of Report Initial,Followup
Report Date 10/10/2018
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received09/17/2018
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date01/24/2019
Device Model Number24628
Device Catalogue Number24628
Device Lot Number0020199811
Was Device Available for Evaluation? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received09/26/2018
Is This a Reprocessed and Reused Single-Use Device? No

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