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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION FLEXTOME CUTTING BALLOON; CATHETERS, TRANSLUMINAL CORONARY ANGIOPLASTY, PERCUTANEOUS
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BOSTON SCIENTIFIC CORPORATION FLEXTOME CUTTING BALLOON; CATHETERS, TRANSLUMINAL CORONARY ANGIOPLASTY, PERCUTANEOUS Back to Search Results
Model Number 3822
Device Problem Material Rupture (1546)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 12/04/2019
Event Type  malfunction  
Manufacturer Narrative
Age at time of event: 18 years or older.
 
Event Description
It was reported that a balloon rupture occurred.The target lesion was located in the moderately tortuous and moderately calcified left anterior descending artery.A 10/2.50 flextome cutting balloon was selected for use.During the procedure, it was noted that the balloon ruptured at 6bar.The procedure was completed with another of the same device.No patient complications were reported and the patient was stable post procedure.
 
Event Description
It was reported that a balloon rupture occurred.The target lesion was located in the moderately tortuous and moderately calcified left anterior descending artery.A 10/2.50 flextome cutting balloon was selected for use.During the procedure, it was noted that the balloon ruptured at 6bar.The procedure was completed with another of the same device.No patient complications were reported and the patient was stable post procedure.It was further reported that the balloon was inflated 5 times for 1 second per interval.At 5th inflation, it was noted that the balloon ruptured at 6atm for 6 seconds.Consequently, the balloon was removed slowly and smoothly step by step.The patient was stable post procedure.
 
Manufacturer Narrative
Age at time of event: 18 years or older.
 
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Brand Name
FLEXTOME CUTTING BALLOON
Type of Device
CATHETERS, TRANSLUMINAL CORONARY ANGIOPLASTY, PERCUTANEOUS
Manufacturer (Section D)
BOSTON SCIENTIFIC CORPORATION
two scimed place
maple grove MN 55311
MDR Report Key9437846
MDR Text Key176023227
Report Number2134265-2019-15285
Device Sequence Number1
Product Code NWX
Combination Product (y/n)N
PMA/PMN Number
P950020
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,distri
Type of Report Initial,Followup
Report Date 12/12/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Expiration Date03/27/2021
Device Model Number3822
Device Catalogue Number3822
Device Lot Number0021921535
Was Device Available for Evaluation? No
Initial Date Manufacturer Received 12/04/2019
Initial Date FDA Received12/09/2019
Supplement Dates Manufacturer Received12/04/2019
Supplement Dates FDA Received12/12/2019
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Treatment
BALLOON: EMRGE 2.5 *12; BALLOON: EMRGE 2.5 *12; GUIDE CATHETER: 6F KIMMY; GUIDE CATHETER: 6F KIMMY; GUIDEWIRE: 0.014 TERUMO; GUIDEWIRE: 0.014 TERUMO
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