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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 Device Dislodged or Dislocated (2923); Adverse Event Without Identified Device or Use Problem (2993)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 01/01/2020
Event Type  malfunction  
Manufacturer Narrative
Date of event: date of event is approximated based on notification date.
 
Event Description
It was reported that a blade lifted from the cutting balloon.A 7.00mm / 2.0cm / 90cm peripheral cutting balloon was used in a procedure.Post procedure, when the physician was removing the balloon from the sheath, it was noted that the blade lifted from its position on the balloon.No portion of the device remained in the patients body.There were no patient complications and the patient was reported to be in good condition post procedure.
 
Manufacturer Narrative
B3: date of event: date of event is approximated based on notification date.Device analysis by mfr: a visual examination identified the returned balloon folds were relaxed.The device was attached to an encore inflation device and positive pressure was applied.A pinhole leak was identified 10mm proximal of the distal marker band.An examination of the balloon material and markerbands identified no issues which could potentially have contributed to this complaint.Visual and microscopic examination of the blades and pads found that 15mm of blade had lifted on one of the blades.The blade pad was fully intact.The damage identified is consistent with excessive force being applied when resistance is encountered during the withdrawal of the device.All other blades were intact and fully bonded to the balloon material.No other damage or irregularities were found on the device.
 
Event Description
It was reported that a blade lifted from the cutting balloon.A 7.00mm / 2.0cm / 90cm peripheral cutting balloon was used in a procedure.Post procedure, when the physician was removing the balloon from the sheath, it was noted that the blade lifted from its position on the balloon.No portion of the device remained in the patients body.There were no patient complications and the patient was reported to be in good condition 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
MDR Report Key9659887
MDR Text Key179228216
Report Number2134265-2020-00805
Device Sequence Number1
Product Code LIT
Combination Product (y/n)N
PMA/PMN Number
K070951
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Type of Report Initial,Followup
Report Date 03/02/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received02/03/2020
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Expiration Date06/27/2021
Device Model Number24630
Device Catalogue Number24630
Device Lot Number0024029426
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer01/29/2020
Date Manufacturer Received02/27/2020
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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