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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION SMALL PERIPHERAL CUTTING BALLOON; CATHETERS, TRANSLUMINAL CORONARY ANGIOPLASTY, PERCUTANEOUS
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BOSTON SCIENTIFIC CORPORATION SMALL PERIPHERAL CUTTING BALLOON; CATHETERS, TRANSLUMINAL CORONARY ANGIOPLASTY, PERCUTANEOUS Back to Search Results
Model Number 24658
Device Problems Difficult to Remove (1528); Detachment of Device or Device Component (2907)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 03/14/2023
Event Type  malfunction  
Event Description
It was reported that the balloon and shaft got separated.The 90% stenosed target lesion was located in the mildly tortuous and mildly calcified superficial femoral artery.A 4.00mm/1.5cm/140cm small peripheral cutting balloon was selected for use.During the procedure, when the protector was removed for pcb preparation, it was very difficult to pull out.Consequently, a slight force was applied but the balloon and shaft got separated.The procedure was completed with a different device.No complications were reported, and patient was good post procedure.
 
Manufacturer Narrative
Device evaluated by manufacturer: the device was returned for analysis.The device was received in two sections due to a separation of the shaft.The device was returned with the balloon protector partially removed on the device.For investigation purposes the investigator fully removed the protector without issue.A visual examination identified that the balloon was not subjected to positive pressure.The balloon material and blades of the device were visually examined, and no issues were noted.A visual and tactile examination found the shaft polymer extrusion to be completely separated at the guidewire port.The shaft was also found to be kinked at approximately 80mm distal of the separation.This type of damage is consistent with excessive force being applied to the device.The device was received with the balloon protector partially removed on the device.The investigator was unable to apply a vacuum to the device as per preparation instructions indicated in spcb ifu due to a shaft separation.For investigation purposes the investigator removed the balloon protector from the device.The balloon protector inner diameter was verified at 0.0435 inch using a calibrated pin gauge.This is within the specified range of 0.0420 inches to 0.0435 inches as per drawing.Balloon protector 3.5mm thru 4mm.A visual investigation identified no damage or any issues with the markerbands or tip of the device.
 
Event Description
It was reported that the balloon and shaft got separated.The 90% stenosed target lesion was located in the mildly tortuous and mildly calcified superficial femoral artery.A 4.00mm/1.5cm/140cm small peripheral cutting balloon was selected for use.During the procedure, when the protector was removed for pcb preparation, it was very difficult to pull out.Consequently, a slight force was applied but the balloon and shaft got separated.The procedure was completed with a different device.No complications were reported, and patient was good post procedure.
 
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Brand Name
SMALL PERIPHERAL CUTTING BALLOON
Type of Device
CATHETERS, TRANSLUMINAL CORONARY ANGIOPLASTY, PERCUTANEOUS
Manufacturer (Section D)
BOSTON SCIENTIFIC CORPORATION
300 boston scientific way
marlborough MA 01752
Manufacturer (Section G)
BOSTON SCIENTIFIC IRELAND LIMITED
ballybrit business park
galway
EI  
Manufacturer Contact
jeff wallner
4100 hamline ave n
arden hills, MN 55112
6515811560
MDR Report Key16689469
MDR Text Key312806509
Report Number2124215-2023-14143
Device Sequence Number1
Product Code NWX
Combination Product (y/n)N
Reporter Country CodeJA
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Other,Foreign,Health Professional,Company Representative,Distributor
Reporter Occupation Physician
Type of Report Initial,Followup
Report Date 04/21/2023
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received04/06/2023
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Expiration Date11/10/2023
Device Model Number24658
Device Catalogue Number24658
Device Lot Number0026333296
Was Device Available for Evaluation? Device Returned to Manufacturer
Is the Reporter a Health Professional? Yes
Date Manufacturer Received04/18/2023
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured11/10/2020
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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