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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 Problem Material Rupture (1546)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 12/23/2020
Event Type  malfunction  
Manufacturer Narrative
(b)(6).
 
Event Description
It was reported that a balloon rupture occurred.The 90% stenosed target lesion was located in the mildly tortuous and mildly calcified arteriovenous shunt.A 6.00mm/2.0cm/90cm peripheral cutting balloon was selected for use.During procedure, the balloon was inflated four times at 8atm, 10atm, 10atm and 10atm accordingly within 30 seconds.However, at fourth inflation, it was noted that the balloon ruptured.After this device was removed from the sheath, blades were attached on four directions and no blade remained inside the body.The procedure was completed using the same device.No patient complications were reported.
 
Event Description
It was reported that a balloon rupture occurred.The 90% stenosed target lesion was located in the mildly tortuous and mildly calcified arteriovenous shunt.A 6.00mm/2.0cm/90cm peripheral cutting balloon was selected for use.During procedure, the balloon was inflated four times at 8atm, 10atm, 10atm and 10atm accordingly within 30 seconds.However, at fourth inflation, it was noted that the balloon ruptured.After this device was removed from the sheath, blades were attached on four directions and no blade remained inside the body.The procedure was completed using the same device.No patient complications were reported.
 
Manufacturer Narrative
E1 - initial reporter address 1: (b)(6).E1 - initial reporter city: (b)(6).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.Blood was identified within the balloon which is evidence of a device leak.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 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 Key11073195
MDR Text Key224313461
Report Number2134265-2020-18475
Device Sequence Number1
Product Code LIT
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 01/22/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received12/24/2020
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Expiration Date04/24/2022
Device Model Number24630
Device Catalogue Number24630
Device Lot Number0025467793
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer01/18/2021
Date Manufacturer Received01/22/2021
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Treatment
GUIDEWIRE: GT WIRE; GUIDEWIRE: GT WIRE; INFLATION DEVICE: FUJI MEDICAL INDEFLATOR; INFLATION DEVICE: FUJI MEDICAL INDEFLATOR; INTRODUCER SHEATH: TERUMO 6FR; INTRODUCER SHEATH: TERUMO 6FR
Patient Age60 YR
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