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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 Material Rupture (1546)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 12/03/2019
Event Type  malfunction  
Manufacturer Narrative
(b)(6).
 
Event Description
It was reported that the balloon ruptured.The 100% stenosed shunt.A 6mmx2cmx50cm peripheral cutting balloon was selected for use.During the procedure, it was noted that the balloon ruptured.The procedure was completed with a different device.No patient complications reported.
 
Manufacturer Narrative
(b)(6).
 
Event Description
It was reported that the balloon ruptured.The 100% stenosed shunt.A 6mmx2cmx50cm peripheral cutting balloon was selected for use.During the procedure, it was noted that the balloon ruptured.The procedure was completed with a different device.No patient complications reported.It was further reported that the balloon was simply pulled out from the patient's body and that the patient was stable post procedure.
 
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Brand Name
2CM PERIPHERAL CUTTING BALLOON
Type of Device
CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINA
Manufacturer (Section D)
BOSTON SCIENTIFIC CORPORATION
two scimed place
maple grove MN 55311
MDR Report Key9452551
MDR Text Key176236011
Report Number2134265-2019-15524
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 01/07/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received12/11/2019
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Expiration Date05/27/2021
Device Model Number24628
Device Catalogue Number24628
Device Lot Number0023861365
Was Device Available for Evaluation? No
Date Manufacturer Received12/15/2019
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Treatment
GUIDEWIRE - KYOUSHA; GUIDEWIRE - KYOUSHA; INTRODUCER SHEATH - MOSQUITO; INTRODUCER SHEATH - MOSQUITO
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