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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 3820
Device Problem Detachment of Device or Device Component (2907)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 06/20/2020
Event Type  malfunction  
Event Description
It was reported that the device was fractured.A 06/2.75 flextome cutting balloon was selected for use.During preparation, the cutting balloon was unpacked, and it was found that the balloon was fractured.The procedure was completed with another of the same device.No patient complications reported.
 
Event Description
It was reported that the device was fractured.A 06/2.75 flextome cutting balloon was selected for use.(b)(6) 2020 during the procedure, the physician unpacked the cutting balloon, it was found the balloon was fractured.The procedure was completed with another of same device.There were no complications reported.It was further reported that the patient was fine post procedure.
 
Manufacturer Narrative
E1 initial reporter phone: (b)(6).
 
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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 Key10428247
MDR Text Key203831109
Report Number2134265-2020-11265
Device Sequence Number1
Product Code NWX
Combination Product (y/n)N
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Type of Report Initial,Followup
Report Date 09/29/2020
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 Date12/09/2022
Device Model Number3820
Device Catalogue Number3820
Device Lot Number0024905019
Was Device Available for Evaluation? No
Initial Date Manufacturer Received 08/05/2020
Initial Date FDA Received08/19/2020
Supplement Dates Manufacturer Received09/24/2020
Supplement Dates FDA Received09/29/2020
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Age74 YR
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