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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 Problem Detachment of Device or Device Component (2907)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 09/22/2022
Event Type  malfunction  
Manufacturer Narrative
Initial reporter city: (b)(6).
 
Event Description
It was reported that the balloon and blade came out together.The 90% stenosed target lesion was located in the moderately tortuous and non-calcified vein.A 4.00mm/1.5cm/140cm small peripheral cutting balloon was selected for use.During the preparation, it was noted that when the balloon protective cover of this device was removed, the balloon and the blade came out together.Only the marker remained on the shaft, so the device was discontinued.The procedure was completed with another of the same device.No patient complications reported.
 
Manufacturer Narrative
E1.Initial reporter city-(b)(6).Device evaluated by manufacturer: the device was returned for analysis.A visual examination identified that the balloon section was detached from the device.The device was received with the balloon section inserted in the blue balloon protector.The investigator removed the balloon section from the balloon protector.The balloon was folded which indicates that the balloon was not subjected to positive pressure.A visual examination identified no damage to the blades of the device.All blades were present and fully bonded to the balloon material.Balloon bond markings are visible on the detached balloon and the shaft.No issues were noted with the tip section of the device.A visual examination found no issue with the marker bands.A visual and tactile examination identified no kinks or damage to the shaft or hypotube of the returned device.
 
Event Description
It was reported that the balloon and blade came out together.The 90% stenosed target lesion was located in the moderately tortuous and non-calcified vein.A 4.00mm/1.5cm/140cm small peripheral cutting balloon was selected for use.During the preparation, it was noted that when the balloon protective cover of this device was removed, the balloon and the blade came out together.Only the marker remained on the shaft, so the device was discontinued.The procedure was completed with another of the same device.No patient complications reported.
 
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Brand Name
SMALL PERIPHERAL CUTTING BALLOON
Type of Device
CATHETERS, TRANSLUMINAL CORONARY ANGIOPLASTY, PERCUTANEOUS
Manufacturer (Section D)
BOSTON SCIENTIFIC CORPORATION
two scimed place
maple grove MN 55311
Manufacturer (Section G)
BOSTON SCIENTIFIC IRELAND LIMITED
ballybrit business park
galway
EI  
Manufacturer Contact
jay johnson
4100 hamline ave n
arden hills, MN 55112
6515810888
MDR Report Key15607802
MDR Text Key301760598
Report Number2124215-2022-40420
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 Foreign,Health Professional,Company Representative,Distributor
Reporter Occupation Physician
Type of Report Initial,Followup
Report Date 11/17/2022
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 Date11/10/2023
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
Initial Date Manufacturer Received 09/26/2022
Initial Date FDA Received10/14/2022
Supplement Dates Manufacturer Received10/26/2022
Supplement Dates FDA Received11/17/2022
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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