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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 Difficult to Remove (1528); Device Dislodged or Dislocated (2923)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 11/20/2020
Event Type  malfunction  
Manufacturer Narrative
(b)(6).
 
Event Description
It was reported that the blade was partially peeled off.Vascular access was via common femoral artery.The 50% stenosed target lesion was located in the moderately tortuous renal artery.A 4.00mm/1.5cm/140cm small peripheral cutting balloon was selected for use in pre-inflation.During procedure, the inflation was performed 3 times and the maximum inflation pressure was at 7atm.During removal of the device, a mild resistance was noted.Furthermore, the device was simply pulled out from the patient's body without any issues and it was noted that proximal part of the blade was partially lifted.Moreover, the two blades of this recovered device were peeled off, but this was intentionally peeled off outside the body.No device fragment remained inside the body.No patient complications were reported.
 
Event Description
It was reported that the blade was partially peeled off.Vascular access was via common femoral artery.The 50% stenosed target lesion was located in the moderately tortuous renal artery.A 4.00mm/1.5cm/140cm small peripheral cutting balloon was selected for use in pre-inflation.During procedure, the inflation was performed 3 times and the maximum inflation pressure was at 7atm.During removal of the device, a mild resistance was noted.Furthermore, the device was simply pulled out from the patient's body without any issues and it was noted that proximal part of the blade was partially lifted.Moreover, the two blades of this recovered device were peeled off, but this was intentionally peeled off outside the body.No device fragment remained inside the body.No patient complications were reported.
 
Manufacturer Narrative
E1 - initial reporter city: (b)(6).Device evaluated by mfr: a visual and microscopic examination was performed on the returned device.It was noted that one of the blades and pad was completely detached from the balloon material and it was also noted that a section of another of one of the blades and pad, approximately 4mm in length on the proximal end was detached and was not returned with the device.The remaining section of blade was undamaged and fully bonded to the balloon material.The damage identified can potentially be a result of the resistance encountered during withdrawal of the device.All other blades were intact and fully bonded to the balloon material.A visual and microscopic examination identified no issues with the balloon material.No issue was observed with the tip or markerbands of the device which could have contributed to the complaint incident.A visual and tactile examination identified a shaft polymer extrusion kink 20mm proximal from the guidewire exit port.No other issues were identified during 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
MDR Report Key10928548
MDR Text Key218989754
Report Number2134265-2020-16677
Device Sequence Number1
Product Code NWX
Combination Product (y/n)N
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,distri
Type of Report Initial,Followup
Report Date 12/18/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received12/01/2020
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Expiration Date05/12/2023
Device Model Number24658
Device Catalogue Number24658
Device Lot Number0025506201
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer12/08/2020
Date Manufacturer Received12/16/2020
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Treatment
GUIDE CATHETER: CARDINAL BRITE TIP.; GUIDE CATHETER: CARDINAL BRITE TIP.; GUIDE CATHETER: CARDINAL BRITE TIP
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