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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION 2CM PERIPHERAL CUTTING BALLOON; CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINA
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BOSTON SCIENTIFIC CORPORATION 2CM PERIPHERAL CUTTING BALLOON; CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINA Back to Search Results
Model Number 24630
Device Problems Inflation Problem (1310); Leak/Splash (1354); Material Integrity Problem (2978)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 04/29/2022
Event Type  malfunction  
Event Description
It was reported that a balloon leak occurred.The severe stenosed target lesion was located in a fistula.A 6.00mm/2.0cm/90cm peripheral cutting balloon was selected for use.During the procedure, the balloon was not fully dilated after dilation.It was noted that a contrast agent leaked out after the pressure reached 10atm.Subsequently, the lower end of the balloon got kink and the blade was bent when the device was removed by simply pulling out from the patient's body.The procedure was completed with another of same device.No complications reported and patient was stable post procedure.
 
Manufacturer Narrative
(b)(6).
 
Manufacturer Narrative
E1: initial reporter facility name: (b)(6).Device evaluated by manufacturer: the device was returned for analysis.A visual examination found no damage to the blades of the device.All blades were intact and fully bonded to the balloon material.A visual examination identified that the balloon was not folded which indicates that the device was subjected to positive pressure.The returned device was attached to a boston scientific encore inflation unit.Positive pressure was applied when liquid was observed to be leaking from a balloon pinhole located approximately 2mm distal of the distal markerband.An examination of the balloon material and distal markerband identified no issues which could potentially have contributed to this complaint.The balloon could not be inflated due to the balloon pinhole.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 found the shaft of the device to be kinked at approximately 5mm proximal of the proximal balloon sleeve.This type of damage is consistent with excessive force being applied to the device.
 
Event Description
It was reported that a balloon leak occurred.The severe stenosed target lesion was located in a fistula.A 6.00mm/2.0cm/90cm peripheral cutting balloon was selected for use.During the procedure, the balloon was not fully dilated after dilation.It was noted that a contrast agent leaked out after the pressure reached 10atm.Subsequently, the lower end of the balloon got kink and the blade was bent when the device was removed by simply pulling out from the patient's body.The procedure was completed with another of same device.No complications reported and patient was stable post procedure.
 
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Brand Name
2CM PERIPHERAL CUTTING BALLOON
Type of Device
CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINA
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 Key14523208
MDR Text Key292818593
Report Number2134265-2022-05861
Device Sequence Number1
Product Code LIT
Combination Product (y/n)N
Reporter Country CodeCH
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Foreign,Health Professional,Company Representative
Reporter Occupation Physician
Type of Report Initial,Followup
Report Date 07/20/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received05/27/2022
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Expiration Date07/14/2023
Device Model Number24630
Device Catalogue Number24630
Device Lot Number0027663205
Was Device Available for Evaluation? Device Returned to Manufacturer
Is the Reporter a Health Professional? Yes
Date Manufacturer Received06/28/2022
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured07/14/2021
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
Patient Age70 YR
Patient SexMale
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