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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 11/01/2019
Event Type  malfunction  
Event Description
It was reported that balloon rupture occurred.A 7.00mm x 2.0cm x 90cm peripheral cutting balloon was selected for use.During procedure, it was noted that the balloon ruptured before it reached its nominal pressure.The procedure was completed with another of the same device.No patient complications were reported.
 
Event Description
It was reported that balloon rupture occurred.A 7.00mm x 2.0cm x 90cm peripheral cutting balloon was selected for use.During procedure, it was noted that the balloon ruptured before it reached its nominal pressure.The procedure was completed with another of the same device.No patient complications were reported.It was further reported that the 80% stenosed target lesion was in a severely tortuous and moderately calcified arteriovenous fistula.The balloon ruptured at 10 atm upon second inflation and the patient was normal post procedure.
 
Manufacturer Narrative
Device evaluated by manufacturer: the device was returned for analysis.Based on potential hazards/failure modes the following attributes were considered during analysis: a visual and microscopic examination was performed on the returned device.It was noted that approximately 5mm of the proximal end of one of the blades was lifted distally from the balloon material.The remaining 15mm of the lifted blade and the entire blade pad remained bonded to the balloon material.The damage identified is consistent with excessive force being applied when resistance is encountered during the withdrawal of the device through the sheath.All other blades were intact and fully bonded to the balloon material.A visual examination identified that the balloon was not folded which indicates that the balloon was subjected to positive pressure.A microscopic examination identified a balloon pinhole located approximately 10mm distal of the proximal markerband.An examination of the balloon material and markerbands identified no issues which could potentially have contributed to this complaint.No issue was observed with the tip or markerbands of the device which could have contributed to the complaint incident.A visual and tactile examination found the shaft to be kinked at approximately 355mm proximal of the proximal balloon sleeve.This type of damage is consistent with excessive force being applied to the delivery system.No other issues were identified during the product analysis.
 
Event Description
It was reported that balloon rupture occurred.A 7.00mm x 2.0cm x 90cm peripheral cutting balloon was selected for use.During procedure, it was noted that the balloon ruptured before it reached its nominal pressure.The procedure was completed with another of the same device.No patient complications were reported.It was further reported that the 80% stenosed target lesion was in a severely tortuous and moderately calcified arteriovenous fistula.The balloon ruptured at 10 atm upon second inflation and the patient was normal 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 Key9353782
MDR Text Key173502441
Report Number2134265-2019-14227
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,foreig
Type of Report Initial,Followup,Followup
Report Date 01/16/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received11/21/2019
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Expiration Date02/20/2021
Device Model Number24630
Device Catalogue Number24630
Device Lot Number0023381419
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer11/27/2019
Date Manufacturer Received12/23/2019
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Age77 YR
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