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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 Problems Human-Device Interface Problem (2949); Positioning Problem (3009)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 11/11/2020
Event Type  malfunction  
Event Description
It was reported that the procedure was cancelled.The target lesion area was located in the left circumflex artery.A 06/3.50 flextome cutting balloon was selected for use in a percutaneous coronary intervention.The balloon device was advanced for dilatation.However, the position of the device was not proper after deployment.The device was simply pulled out of the patient's body.The physician noted that they thought they chose the incorrect device and it could not cure the patient.The procedure was cancelled.There were no patient complications reported.
 
Manufacturer Narrative
F10.Additional device code "human device interface problem".
 
Event Description
It was reported that the procedure was cancelled.The target lesion area was located in the left circumflex artery.A 06/3.50 flextome cutting balloon was selected for use in a percutaneous coronary intervention.The balloon device was advanced for dilatation.However, the position of the device was not proper after deployment.The device was simply pulled out of the patient's body.The physician noted that they thought they chose the incorrect device and it could not cure the patient.The procedure was cancelled.There were no patient complications reported.It was further reported that after use in the patient, the physician felt that the device size was not ideal to cure the patient.
 
Manufacturer Narrative
F10.Additional device code "human device interface problem".Device evaluated by manufacturer: the device was returned for analysis.A visual and tactile examination identified no kinks or damages.A visual examination identified that the balloon was in a deflated state.An examination of the balloon identified no issues which could potentially have contributed to this complaint.A visual and microscopic examination identified no damage to the tip, markerbands or blades of the device.All blades were present and fully bonded to the balloon material.No other issues were identified during the product analysis.
 
Event Description
It was reported that the procedure was cancelled.The target lesion area was located in the left circumflex artery.A 06/3.50 flextome cutting balloon was selected for use in a percutaneous coronary intervention.The balloon device was advanced for dilatation.However, the position of the device was not proper after deployment.The device was simply pulled out of the patient's body.The physician noted that they thought they chose the incorrect device and it could not cure the patient.The procedure was cancelled.There were no patient complications reported.It was further reported that after use in the patient, the physician felt that the device size was not ideal to cure the patient.
 
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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 Key10875177
MDR Text Key219172832
Report Number2134265-2020-16142
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,Followup
Report Date 01/06/2021
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 Date11/14/2022
Device Model Number3820
Device Catalogue Number3820
Device Lot Number0024774603
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer11/30/2020
Initial Date Manufacturer Received 11/12/2020
Initial Date FDA Received11/20/2020
Supplement Dates Manufacturer Received11/23/2020
12/22/2020
Supplement Dates FDA Received11/25/2020
01/06/2021
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Age58 YR
Patient Weight71
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