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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 24634
Device Problem Material Rupture (1546)
Patient Problems No Consequences Or Impact To Patient (2199); No Clinical Signs, Symptoms or Conditions (4582)
Event Date 01/13/2021
Event Type  malfunction  
Event Description
It was reported that a balloon rupture occurred.Vascular access was obtained via contralateral approach.The 75% stenosed target lesion was located in the moderately tortuous and moderately calcified right superficial femoral artery.A 6.00mmx2.0cmx135cm peripheral cutting balloon was selected for use.A plain old balloon angioplasty was performed using a non-boston scientific balloon catheter.During additional dilation by this device in the residual stenosis, it was noted that the balloon ruptured upon second inflation at 5 to 6 atmospheres for about 20 seconds.The balloon was removed without disconnection from the patient's body and the procedure was completed with another of the same device.No complications were reported and there was no patient injury.
 
Event Description
It was reported that a balloon rupture occurred.Vascular access was obtained via contralateral approach.The 75% stenosed target lesion was located in the moderately tortuous and moderately calcified right superficial femoral artery.A 6.00mmx2.0cmx135cm peripheral cutting balloon was selected for use.A plain old balloon angioplasty was performed using a non-boston scientific balloon catheter.During additional dilation by this device in the residual stenosis, it was noted that the balloon ruptured upon second inflation at 5 to 6 atmospheres for about 20 seconds.The balloon was removed without disconnection from the patient's body and the procedure was completed with another of the same device.No complications were reported and there was no patient injury.
 
Manufacturer Narrative
Device evaluated by mfr: the device was returned for analysis.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.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 11mm proximal of the distal markerband.An examination of the balloon material and markerbands identified no issues which could potentially have contributed to this complaint.A visual and microscopic examination observed no damage to the tip or blades.All blades were present and fully bonded to the balloon surface.A visual and tactile examination identified no kinks or damage to the shaft of the device.No other issues were identified during the product analysis.
 
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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 Key11206857
MDR Text Key227953585
Report Number2134265-2021-00516
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 02/15/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Expiration Date05/18/2022
Device Model Number24634
Device Catalogue Number24634
Device Lot Number0025518549
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer01/25/2021
Initial Date Manufacturer Received 01/13/2021
Initial Date FDA Received01/21/2021
Supplement Dates Manufacturer Received01/28/2021
Supplement Dates FDA Received02/15/2021
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Treatment
GUIDEWIRE - AGURUS; GUIDEWIRE - AGURUS; INTRODUCER SHEATH - PARENT 6FR; INTRODUCER SHEATH - PARENT 6FR; GUIDEWIRE - AGURUS; INTRODUCER SHEATH - PARENT 6FR
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