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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 Leak/Splash (1354); Material Rupture (1546)
Patient Problem Perforation of Vessels (2135)
Event Date 12/18/2018
Event Type  Injury  
Manufacturer Narrative
Age at time of event: 18 years or older.
 
Event Description
It was reported that patient experienced minor vascular perforation.The 80% stenosed target lesion was located at the vein shunt.A 4.00mm/1.5cm/140cm small peripheral cutting balloon was selected fro use.During the procedure, at second dilatation, it was noted that balloon pinhole rupture occurred at 12atm and the patient experienced minor perforation from the blood vessel.The procedure was completed after hemostasis with a non bsc device.No further patient complications were reported and the patient was stable after treatment.
 
Manufacturer Narrative
Age at time of event: 18 years or older.Device evaluated by mfr: product analysis identified a balloon pinhole and hypotube kinks.This type of damage is consistent with excessive force being applied to the device.There is no evidence that the device failed to meet spcb flextome specification prior to shipping.The use of this flextome device indicates the requirement for dilatation and lesion scoring.The device encountered difficult patient anatomy as it was stated that there were two lesions with 80% stenosis, which would have contributed to the complaint incident.As there were no kinks reported in the event, the kinks on the hypotube may have occurred when the device was being returned for analysis.A visual examination identified that the balloon was not folded which indicates that the balloon was subjected to positive pressure.Blood was identified within the balloon and inflation lumen which is evidence of a device leak.The returned device was attached to an encore inflation unit.Positive pressure was applied when liquid was observed to be leaking from a balloon pinhole located approximately 9mm distal to the distal end of the proximal markerband.An examination of the balloon material and markerbands identified no issues which could potentially have contributed to this complaint.A visual and microscopic examination observed no damage to the tip or blades.All blades were present and fully bonded to the balloon surface.
 
Event Description
It was reported that patient experienced minor vascular perforation.The 80% stenosed target lesion was located at the vein shunt.A 4.00mm/1.5cm/140cm small peripheral cutting balloon was selected fro use.During the procedure, at second dilatation, it was noted that balloon pinhole rupture occurred at 12atm and the patient experienced minor perforation from the blood vessel.The procedure was completed after hemostasis with a non bsc device.No further patient complications were reported and the patient was stable after treatment.
 
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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
MDR Report Key8233458
MDR Text Key132597624
Report Number2134265-2018-64772
Device Sequence Number1
Product Code NWX
Combination Product (y/n)N
PMA/PMN Number
P950020
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,distri
Type of Report Initial,Followup
Report Date 02/19/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator Health Professional
Device Expiration Date02/05/2021
Device Model Number24658
Device Catalogue Number24658
Device Lot Number0021708449
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer01/11/2019
Initial Date Manufacturer Received 12/18/2018
Initial Date FDA Received01/10/2019
Supplement Dates Manufacturer Received01/31/2019
Supplement Dates FDA Received02/19/2019
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Treatment
GUIDEWIRE: JUPITERFC; GUIDEWIRE: JUPITERFC; INTRODUCER SHEATH: 6FR SHEATH; INTRODUCER SHEATH: 6FR SHEATH; GUIDEWIRE: JUPITERFC; INTRODUCER SHEATH: 6FR SHEATH
Patient Outcome(s) Other;
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