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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 11/07/2019
Event Type  malfunction  
Event Description
It was reported that the balloon was leaking.A 10/3.00 flextome cutting balloon was selected for use.During the procedure, when the physician advanced the balloon into the patient body, the balloon was leaking gas and it didn't inflate; however, the physician didn't notice a hole on the balloon.The device was removed from the patient's body without any intervention.The procedure was completed with another of the same device.There were no complications reported and the patient's condition was stable post procedure.
 
Event Description
It was reported that the balloon was leaking.A 10/3.00 flextome cutting balloon was selected for use.During the procedure, when the physician advanced the balloon into the patient body, the balloon was leaking gas and it didn't inflate; however, the physician didn't notice a hole on the balloon.The device was removed from the patient's body without any intervention.The procedure was completed with another of the same device.There were no complications reported and the patient's condition was stable post procedure.
 
Manufacturer Narrative
Device evaluated by manufacturer: the device was returned for analysis.A visual examination identified that the balloon was not folded which indicates that the balloon was subjected to positive pressure.Blood was identified within the balloon and lumen which is evidence of a device leak.The returned device was attached to an encore inflation unit and positive pressure was applied in an attempt to inflate the balloon.The balloon could not be inflated due to the presence of solidified blood that was present within the inflation lumen.The device was soaked in a water bath at a temperature of 37 degrees celsius to help soften the blood before further inflation attempts were made.The device was removed from the bath and the balloon was again attached to an inflation device subjected to positive pressure, but the investigator was still unable to inflate the device.A microscopic examination identified a balloon pinhole located approximately 2mm proximal of the distal markerband.An examination of the balloon material and distal markerband identified no issues which could potentially have contributed to this complaint.The rated burst pressure for this device is 12 atmospheres.No issues were noted with the tip section of the device.A visual and microscopic examination found no issue with the markerbands.A visual and tactile examination found no issues or damage to the shaft or hypotube of the device.No other issues were identified during the product analysis.
 
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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 Key9378179
MDR Text Key174186140
Report Number2134265-2019-14506
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 01/24/2020
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 Date09/18/2021
Device Model Number3822
Device Catalogue Number3822
Device Lot Number0022673236
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer12/05/2019
Initial Date Manufacturer Received 11/11/2019
Initial Date FDA Received11/26/2019
Supplement Dates Manufacturer Received01/06/2020
Supplement Dates FDA Received01/24/2020
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Age72 YR
Patient Weight65
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