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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 06/22/2022
Event Type  malfunction  
Event Description
It was reported that a shaft separation occurred.The 99% stenosed target lesion was located in the moderately tortuous and severely calcified superficial femoral artery.A 4.00mm/1.5cm/140cm small peripheral cutting balloon was selected for use.It was noted that the blue balloon protector was hard to pull and the shaft got separated, outside of the patient.The procedure was completed with another of the same device.There were no complications reported.
 
Manufacturer Narrative
(b)(6).
 
Event Description
It was reported that a shaft separation occurred.The 99% stenosed target lesion was located in the moderately tortuous and severely calcified superficial femoral artery.A 4.00mm/1.5cm/140cm small peripheral cutting balloon was selected for use.It was noted that the blue balloon protector was hard to pull and the shaft got separated, outside of the patient.The procedure was completed with another of the same device.There were no complications reported.
 
Manufacturer Narrative
E1.Initial reporter city- (b)(6).Device evaluated by manufacturer: the device was returned for analysis.A visual and tactile examination identified a complete break in the polymer extrusion 262mm proximal of the distal tip.This type of damage is consistent with excessive force being applied to the delivery system.A visual examination identified that the balloon protector was still on the balloon but had moved in a distal direction.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 folds on the proximal end were relaxed as they were not covered by the balloon protector.An examination of the balloon identified no issues which could potentially have contributed to this complaint.The balloon protectors inner diameter was verified at 0.0435 inch using a calibrated pin gauge ((b)(6)).This is within the specified range of 0.0420 inches to 0.0435 inches.Balloon protector 3.5mm thru 4mm.A visual examination identified no damage to the tip, marker bands or blades of the device.All blades were present and fully bonded to the balloon material.
 
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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 Key15008507
MDR Text Key304018965
Report Number2134265-2022-07633
Device Sequence Number1
Product Code NWX
Combination Product (y/n)N
Reporter Country CodeJA
PMA/PMN Number
P950020
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 08/24/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received07/13/2022
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Expiration Date11/03/2023
Device Model Number24658
Device Catalogue Number24658
Device Lot Number0026293875
Was Device Available for Evaluation? Device Returned to Manufacturer
Is the Reporter a Health Professional? Yes
Date Manufacturer Received08/04/2022
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured11/03/2020
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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