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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 24628
Device Problems Material Rupture (1546); Detachment of Device or Device Component (2907)
Patient Problem Hemorrhage/Bleeding (1888)
Event Date 11/25/2021
Event Type  Injury  
Manufacturer Narrative
(b)(6).
 
Event Description
It was reported that blade separation, balloon rupture and bleeding occurred.The 75% stenosed target lesion was located in the moderately tortuous and non-calcified antebrachium.A 5.00mm/2.0cm/50cm peripheral cutting balloon was selected for use.During the procedure, five of the antebrachium sites were dilated from distal to nominal.However, it was not fully dilated, therefore, it was dilated at 10atm.The remaining three sites were dilated at 10atm, however it was noted that the balloon ruptured at 4atm in the proximal lesion.A blade separation was confirmed via echo.The blade fragment was confirmed near the sheath.Another 6fr sheath was placed on the peripheral side, and biopsy forceps were used to catch and recover it in the sheath under echo.The sheath was pulled out and bleeding has stopped.All the blades have been removed and no fragment remains inside the patient.The procedure was completed with the original device.No further patient complications were reported.
 
Manufacturer Narrative
E1 - initial reporter city: mizunami gifu prefecture 5096101.Device evaluated by mfr: the device was returned for evaluation.A visual examination identified that the balloon was not folded which indicates that the device was subjected to positive pressure.The rated burst pressure for this device is 10 atmospheres as per pcb2cm specification.The returned device was attached to an encore inflation unit.Positive pressure was applied when liquid was observed to be leaking from a balloon pinhole located approximately 6mm proximal of the distal marker band.A visual examination of the returned device identified that one of the blades was completely detached from the balloon.The detached blade was returned for analysis and the entire blade was found to be intact and accounted for.All other blades were present and fully bonded to the balloon surface.No issues were noted with the tip section of the device.A visual and microscopic examination found no issue with the marker bands.A visual and tactile examination identified no kinks or damage to the shaft of the returned device.
 
Event Description
It was reported that blade separation, balloon rupture and bleeding occurred.The 75% stenosed target lesion was located in the moderately tortuous and non-calcified antebrachium.A 5.00mm/2.0cm/50cm peripheral cutting balloon was selected for use.During the procedure, five of the antebrachium sites were dilated from distal to nominal.However, it was not fully dilated, therefore, it was dilated at 10atm.The remaining three sites were dilated at 10atm, however it was noted that the balloon ruptured at 4atm in the proximal lesion.A blade separation was confirmed via echo.The blade fragment was confirmed near the sheath.Another 6fr sheath was placed on the peripheral side, and biopsy forceps were used to catch and recover it in the sheath under echo.The sheath was pulled out and bleeding has stopped.All the blades have been removed and no fragment remains inside the patient.The procedure was completed with the original device.No further patient complications were reported.
 
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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
two scimed place
maple grove, MN 55311
7634942574
MDR Report Key13172935
MDR Text Key283296151
Report Number2134265-2021-16261
Device Sequence Number1
Product Code LIT
Combination Product (y/n)N
Reporter Country CodeJA
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Foreign,Health Professional,Company Representative,Distributor
Reporter Occupation Physician
Type of Report Initial,Followup
Report Date 02/16/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received01/05/2022
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Expiration Date08/05/2023
Device Model Number24628
Device Catalogue Number24628
Device Lot Number0027783158
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer01/17/2022
Is the Reporter a Health Professional? Yes
Date Manufacturer Received01/26/2022
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured08/05/2021
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
Treatment
GUIDEWIRE: TERUMO RADIFOCUS; GUIDEWIRE: TERUMO RADIFOCUS; INTRODUCER SHEATH: MEDIKIT ULTRA HIGH FLOW; INTRODUCER SHEATH: MEDIKIT ULTRA HIGH FLOW
Patient Outcome(s) Required Intervention;
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