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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 Break (1069); Difficult to Remove (1528)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 07/08/2022
Event Type  malfunction  
Event Description
It was reported that the device separated.The target lesion was located in the arteriovenous fistula at the vein side.A 3.50mm/1.5cm/140cm small peripheral cutting balloon was selected for use.During the procedure, the balloon cover was very hard in an attempt to remove it.Subsequently, the catheter was separated when it was strongly pulled out.The procedure was completed with another of same device.No patient complications were reported.
 
Manufacturer Narrative
Initial reporter facility name: (b)(6) hospital.
 
Event Description
It was reported that the device separated.The target lesion was located in the arteriovenous fistula at the vein side.A 3.50mm/1.5cm/140cm small peripheral cutting balloon was selected for use.During the procedure, the balloon cover was very hard in an attempt to remove it.Subsequently, the catheter was separated when it was strongly pulled out.The procedure was completed with another of same device.No patient complications were reported.
 
Manufacturer Narrative
E1 - initial reporter facility name: (b)(6).Device evaluated by manufacturer: the device was returned for analysis.The device was returned with the balloon protector partially removed from 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 that may have potentially contributed to the complaint incident.All blades were fully bonded to the balloon material.A visual and tactile examination found the shaft polymer extrusion to be completely detached at the guidewire port.This type of damage is consistent with excessive tensile force being applied to the device.The device was received with the balloon protector in place 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 break.For investigation purposes the investigator removed the balloon protector with a little resistance experienced as negative pressure could not be applied to the device.The balloon protectors' 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 of the device that could have contributed to the complaint incident.This concludes the product analysis.
 
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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 Key15164191
MDR Text Key297727143
Report Number2124215-2022-28024
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 08/30/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received08/04/2022
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Expiration Date01/22/2023
Device Model Number24658
Device Catalogue Number24658
Device Lot Number0025089110
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer07/27/2022
Is the Reporter a Health Professional? Yes
Date Manufacturer Received08/09/2022
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured01/23/2020
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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