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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 Deflation Problem (1149); Material Rupture (1546)
Patient Problems No Consequences Or Impact To Patient (2199); No Clinical Signs, Symptoms or Conditions (4582)
Event Date 12/18/2020
Event Type  malfunction  
Manufacturer Narrative
(b)(6).
 
Event Description
It was reported that the balloon ruptured and could not deflate.The 95% stenosed target lesion area was located in a moderately tortuous blood vessel.A 4.00mm/1.5cm/140cm flextome small peripheral cutting balloon was selected for use in a percutaneous transluminal angioplasty of the shunt.During the procedure, it was noted that the balloon ruptured below the rated burst pressure.Also, the balloon could not deflate.The balloon device was removed by slowly pulling it out over time and the procedure was completed with another of the same device.There were no complications reported and the patient was stable post procedure.
 
Manufacturer Narrative
E1.Initial reporter address 1:(b)(6).E1.Initial reporter city: (b)(6).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 and no drop in pressure or leaks were noted.A vacuum was then applied, and the balloon deflated fully.The balloon was inflated to its rated burst pressure and deflated on three more occasions with no leaks noted in the device.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 damaged to the shaft of the device.
 
Event Description
It was reported that the balloon ruptured and could not deflate.The 95% stenosed target lesion area was located in a moderately tortuous blood vessel.A 4.00mm/1.5cm/140cm flextome small peripheral cutting balloon was selected for use in a percutaneous transluminal angioplasty of the shunt.During the procedure, it was noted that the balloon ruptured below the rated burst pressure.Also, the balloon could not deflate.The balloon device was removed by slowly pulling it out over time and the procedure was completed with another of the same device.There were no complications reported and the patient was stable post procedure.
 
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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 Key11117774
MDR Text Key225124345
Report Number2134265-2020-18497
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 03/02/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received01/05/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Expiration Date03/13/2023
Device Model Number24658
Device Catalogue Number24658
Device Lot Number0025355043
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer02/18/2021
Date Manufacturer Received02/26/2021
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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