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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BOSTON SCIENTIFIC - GALWAY FLEXTOME¿ CUTTING BALLOON¿; CATHETERS, TRANSLUMINAL CORONARY ANGIOPLASTY, PERCUTANEOUS
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BOSTON SCIENTIFIC - GALWAY FLEXTOME¿ CUTTING BALLOON¿; CATHETERS, TRANSLUMINAL CORONARY ANGIOPLASTY, PERCUTANEOUS Back to Search Results
Model Number H749RB4275100
Device Problem Fluid/Blood Leak (1250)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 05/10/2018
Event Type  malfunction  
Manufacturer Narrative
Age at the time of event: 18 years or older.(b)(4).
 
Event Description
It was reported that there was contrast leakage.A 10/2.75 flextome¿ cutting balloon¿ was selected for use.During the procedure, a contrast leakage was observed from the distal tip under cine angiocardiography image.The procedure was completed with this device.No patient complications were reported and the patient's status was stable.
 
Manufacturer Narrative
Device evaluated by manufacturer: the device was returned for analysis.The balloon was observed to be unfolded and solidified saline solution was present within the balloon which indicated it had been subjected to positive pressure.The returned device was attached to an encore inflation unit and positive pressure was applied to inflate the balloon.The balloon could not be inflated due to the presence of solidified saline solution that was present within the balloon and inflation lumen.The device was soaked in a water bath at a temperature of 37 degrees celsius to help soften the solidified saline solution before further inflation attempts were made.The device was removed from the bath and again attached to an encore inflation unit and positive pressure was applied, the balloon was inflated to its rate of burst pressure of 12 atmospheres for 30 seconds which was recorded with digital timer.The inflation device was verified at 12 atmospheres, before and after use with a calibrated pressure gauge.This inflation to rate of burst pressure of 12 atmospheres was repeated three times and with no leaks or drop in pressure noted.No issues were noted with the balloon inflation.This test was repeated with glycerol/h20 solution and no issues were noted.A visual and tactile examination was performed on the device while the balloon was fully inflated.No damage or any leaks were noted along the length of the shaft.No issues were noted with the shaft that could have contributed to the complaint incident.The markerbands, blades and tip section of the device were visually and microscopically examined and no issues were noted with the device.No other issues were identified during the product analysis.The investigation conclusion is not confirmed - returned as there was no evidence of either the alleged issue(s) or any defect which could have contributed to the event.(b)(4).
 
Event Description
It was reported that there was contrast leakage.A 10/2.75 flextome¿ cutting balloon¿ was selected for use.During the procedure, a contrast leakage was observed from the distal tip under cine angiocardiography image.The procedure was completed with this device.No patient complications were reported and the patient's status was stable.
 
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Brand Name
FLEXTOME¿ CUTTING BALLOON¿
Type of Device
CATHETERS, TRANSLUMINAL CORONARY ANGIOPLASTY, PERCUTANEOUS
Manufacturer (Section D)
BOSTON SCIENTIFIC - GALWAY
Manufacturer (Section G)
BOSTON SCIENTIFIC - GALWAY
Manufacturer Contact
sonali arangil
one scimed place
maple grove, MN 55311
7634941700
MDR Report Key7563511
MDR Text Key109891297
Report Number2134265-2018-05021
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
Reporter Occupation Physician
Type of Report Initial,Followup
Report Date 05/10/2018
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 Date02/11/2021
Device Model NumberH749RB4275100
Device Catalogue NumberRB427510
Device Lot Number21731069
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer05/15/2018
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received 05/10/2018
Initial Date FDA Received06/01/2018
Supplement Dates Manufacturer Received06/02/2018
Supplement Dates FDA Received06/13/2018
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured02/12/2018
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
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