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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 12/04/2019
Event Type  malfunction  
Manufacturer Narrative
(b)(6).
 
Event Description
It was reported that a balloon rupture occurred.The 75% stenosed target lesion was located in the moderately tortuous and mildly calcified vein.A 6.00mm/ 2.0cm/ 90cm peripheral cutting balloon was selected for use.During the procedure, it was noted that the balloon ruptured.The procedure was completed with another of the same device.There was no patient complications reported.
 
Event Description
It was reported that a balloon rupture occurred.The 75% stenosed target lesion was located in the moderately tortuous and mildly calcified vein.A 6.00mm/ 2.0cm/ 90cm peripheral cutting balloon was selected for use.During the procedure, it was noted that the balloon ruptured.The procedure was completed with another of the same device.There was no patient complications reported.It was further reported that the balloon ruptured at first inflation at 10atm for approximately 10 seconds.The device was simply pulled out from the patient's body.The patient was stable post procedure.
 
Manufacturer Narrative
Initial reporter city: (b)(6).
 
Manufacturer Narrative
(b)(6).Device evaluated by manufacturer: the device was returned for analysis.A visual examination identified that the balloon was not folded which indicates that the balloon was subjected to positive pressure.No tears or holes were visible in the balloon.The device was attached to an encore inflation device and positive pressure was applied and device was inflated to its rated burst pressure (rpb) of 10 atmospheres as per directions for use.The inflation device was verified with a calibrated pressure gauge.The device was again inflated to its rpb and was held for 30 seconds without any drop in pressure.The balloon was deflated without issue and the inflation device was verified using the calibrated pressure gauge.All blades were fully bonded onto the balloon with no issues identified.No issues were noted with the tip section of the device.A visual and microscopic examination found no issue with the markerbands.A visual and tactile examination found that the shaft was kinked 30mm proximal from the proximal markerband.No other issues were identified during the product analysis.
 
Event Description
It was reported that a balloon rupture occurred.The 75% stenosed target lesion was located in the moderately tortuous and mildly calcified vein.A 6.00mm/ 2.0cm/ 90cm peripheral cutting balloon was selected for use.During the procedure, it was noted that the balloon ruptured.The procedure was completed with another of the same device.There was no patient complications reported.It was further reported that the balloon ruptured at first inflation at 10atm for approximately 10 seconds.The device was simply pulled out from the patient's body.The 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
MDR Report Key9450663
MDR Text Key176230538
Report Number2134265-2019-15481
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,distri
Type of Report Initial,Followup,Followup
Report Date 02/11/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received12/11/2019
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Expiration Date04/09/2021
Device Model Number24630
Device Catalogue Number24630
Device Lot Number0023621632
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer12/17/2019
Date Manufacturer Received01/20/2020
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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