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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 Problem Device Dislodged or Dislocated (2923)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 11/04/2020
Event Type  malfunction  
Manufacturer Narrative
Initial reporter address (b)(6).
 
Event Description
It was reported that the blade lifted.The diffused stenosed target lesion was located in the severely intimal thick vein.A 5.00mm/2.0cm/50cm peripheral cutting balloon was selected for use.During procedure, a sheath was used and the balloon was inserted smoothly without issues.Inflation was performed with this device 11 times and all stenosed sections were inflated.The balloon was then removed slowly and carefully not to tear the sheath; no resistance was felt.However, a section of the blade was noticed to be lifted when the device was checked after removal.It was confirmed under fluoroscopy that there was no remaining blade in the body and the procedure was completed.The actual device was checked and noted to be slightly bulged since it had been awhile from the actual procedure.No complications were reported and patient was good post procedure.
 
Manufacturer Narrative
E1: initial reporter address 1 (b)(6).Device evaluated by manufacturer: the device was returned for analysis.A visual and microscopic examination was performed on the returned device.It was noted that approximately 14mm of the proximal end of one of the blades was lifted distally from the balloon material.The remaining 6mm of the blade and 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.The returned device was attached to a boston scientific encore inflation unit.Positive pressure was applied when liquid was observed to be leaking from a balloon pinhole located approximately 3mm distal of the distal markerband.An examination of the balloon material and distal markerband 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 no kinks or damage to the shaft of the device.No other issues were identified during the product analysis.
 
Event Description
It was reported that the blade lifted.The diffused stenosed target lesion was located in the severely intimal thick vein.A 5.00mm/2.0cm/50cm peripheral cutting balloon was selected for use.During procedure, a sheath was used and the balloon was inserted smoothly without issues.Inflation was performed with this device 11 times and all stenosed sections were inflated.The balloon was then removed slowly and carefully not to tear the sheath; no resistance was felt.However, a section of the blade was noticed to be lifted when the device was checked after removal.It was confirmed under fluoroscopy that there was no remaining blade in the body and the procedure was completed.The actual device was checked and noted to be slightly bulged since it had been awhile from the actual procedure.No complications were reported and patient was good 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 Key10876803
MDR Text Key217663292
Report Number2134265-2020-16109
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 12/14/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received11/20/2020
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Expiration Date08/25/2022
Device Model Number24628
Device Catalogue Number24628
Device Lot Number0025911962
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer12/02/2020
Date Manufacturer Received12/04/2020
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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