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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 Deflation Problem (1149)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 11/18/2020
Event Type  malfunction  
Manufacturer Narrative
(b)(6).
 
Event Description
It was reported that the balloon did not deflate.The 75% stenosed target lesion area was located in a moderately tortuous and moderately calcified shunt limbs.A 4.00mm/1.5cm/140cm small peripheral cutting balloon was selected for use in a percutaneous transluminal angioplasty.The balloon device crossed through the guidewire.When dilating the lesion with the balloon, it did not inflate.The device was removed from the patient's body and it inflated with no pinhole or rupture.However, the balloon did not deflate when negative pressure was applied.The procedure was completed with another of the same device.There were no patient complications reported.
 
Event Description
It was reported that the balloon did not deflate.The 75% stenosed target lesion area was located in a moderately tortuous and moderately calcified shunt limbs.A 4.00mm/1.5cm/140cm small peripheral cutting balloon was selected for use in a percutaneous transluminal angioplasty.The balloon device crossed through the guidewire.When dilating the lesion with the balloon, it did not inflate.The device was removed from the patient's body and it inflated with no pinhole or rupture.However, the balloon did not deflate when negative pressure was applied.The procedure was completed with another of the same device.There were no patient complications reported.
 
Manufacturer Narrative
E1: initial reporter city: (b)(6) prefecture 3330847 device evaluated by manufacturer: the device was returned for analysis.A visual examination identified that the balloon was not folded which indicates that the balloon was subjected to positive pressure.The device was attached to an encore inflation unit and the balloon was inflated to its rated burst pressure of 12 atmospheres using inflation media glycerol/water and no leaks were noted.A vacuum was then applied, and the balloon deflated fully in 15 seconds.The deflation time was verified using digital timer.As per spcb flextome specification, "the deflation time from rated burst pressure must be less than 20 seconds." the balloon was inflated to its rated burst pressure and deflated on three more occasions with no leaks noted in the device.The times were measured at 18, 15, 18 seconds.The inflation device was verified at 12 atmospheres before and after use with a calibrated pressure gauge.An examination of the balloon material identified no issues which could potentially have contributed to this complaint.A visual and microscopic examination identified no damage or issues with the markerbands or blades of the device that could have contributed to the complaint incident.All blades were present and fully bonded to the balloon material.A visual and microscopic examination identified no issues with the tip of the device that could have contributed to the complaint incident.A visual and tactile examination found no kinks or damage along the shaft of the device.
 
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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 Key10905635
MDR Text Key219197310
Report Number2134265-2020-16403
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 12/15/2020
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 Date05/18/2023
Device Model Number24658
Device Catalogue Number24658
Device Lot Number0025518540
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer12/03/2020
Initial Date Manufacturer Received 11/18/2020
Initial Date FDA Received11/25/2020
Supplement Dates Manufacturer Received12/11/2020
Supplement Dates FDA Received12/16/2020
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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