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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION 2CM PERIPHERAL CUTTING BALLOON; CATHETER, PERCUTANEOUS, CUTTING/SCORING
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BOSTON SCIENTIFIC CORPORATION 2CM PERIPHERAL CUTTING BALLOON; CATHETER, PERCUTANEOUS, CUTTING/SCORING Back to Search Results
Model Number 24628
Device Problems Detachment of Device or Device Component (2907); Adverse Event Without Identified Device or Use Problem (2993)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 03/08/2024
Event Type  malfunction  
Event Description
It was reported that blade detachment occurred.The 95% stenosed target lesion was located in the moderately tortuous and mildly calcified inner shunt forearm.A 5.00mm / 2.0cm / 50cm 2cm peripheral cutting balloon was advanced for dilation.After the lesion was properly dilated, the device was removed as usual.It was then noted that the blade of the balloon proximal part got damaged and was partially separated from the balloon.The calcification was not severe, and since the sheath was able to insert without issue, physician stated that there was no particular reason that could be found that caused the separation.No stent was placed in the lesion.The procedure was completed using this device.There were no complications reported, and patient status after surgery was good.
 
Manufacturer Narrative
Device evaluated by mfr.: a visual examination was performed on the returned device.It was identified that the balloon was not folded which indicates that the device was subjected to positive pressure.A visual examination of the returned device identified that the balloon had been inflated.The investigator filled the balloon with liquid to facilitate an inspection of the blades when the liquid was observed leaking from a balloon pinhole located approximately 8mm proximal of the distal markerband.Additionally, it was noted that approximately 10mm of the proximal end of one of the blades was lifted distally from its pad.The damage identified is consistent with excessive force being applied when resistance is encountered during the withdrawal of the device through the sheath.All other blades were intact and fully bonded to the balloon material.No issue was observed with the tip or markerbands of the device.A visual and tactile examination found no kinks or damage to the shaft of the device.
 
Event Description
It was reported that blade detachment occurred.The 95% stenosed target lesion was located in the moderately tortuous and mildly calcified inner shunt forearm.A 5.00mm / 2.0cm / 50cm 2cm peripheral cutting balloon was advanced for dilation.After the lesion was properly dilated, the device was removed as usual.It was then noted that the blade of the balloon proximal part got damaged and was partially separated from the balloon.The calcification was not severe, and since the sheath was able to insert without issue, physician stated that there was no particular reason that could be found that caused the separation.No stent was placed in the lesion.The procedure was completed using this device.There were no complications reported, and patient status after surgery was good.It was further reported that the other half of the blade came off of inside the sheath.
 
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Brand Name
2CM PERIPHERAL CUTTING BALLOON
Type of Device
CATHETER, PERCUTANEOUS, CUTTING/SCORING
Manufacturer (Section D)
BOSTON SCIENTIFIC CORPORATION
300 boston scientific way
marlborough MA 01752
Manufacturer (Section G)
BOSTON SCIENTIFIC CORPORATION
ballybrit business park
galway
EI  
Manufacturer Contact
rachel shields
4100 hamline ave n
arden hills, MN 55112
6512422111
MDR Report Key19028204
MDR Text Key339207845
Report Number2124215-2024-19849
Device Sequence Number1
Product Code PNO
Combination Product (y/n)N
Reporter Country CodeJA
PMA/PMN Number
K151253
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Other,Foreign,Health Professional,Company Representative
Reporter Occupation Physician
Type of Report Initial,Followup
Report Date 04/25/2024
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received04/02/2024
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Model Number24628
Device Catalogue Number24628
Device Lot Number0032603370
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer03/21/2024
Is the Reporter a Health Professional? Yes
Date Manufacturer Received04/03/2024
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured10/10/2023
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
Treatment
GUIDEWIRE: RADIFOCUS.; GUIDEWIRE: RADIFOCUS.; INTRODUCER SHEATH: 6FR ULTRA HIGH FLOW.; INTRODUCER SHEATH: 6FR ULTRA HIGH FLOW.
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