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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 Problems Deflation Problem (1149); Difficult to Remove (1528)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 09/02/2020
Event Type  Injury  
Event Description
It was reported that the balloon failed to deflate and was difficult to remove.A 6.00mm/2.0cm/50cm peripheral cutting balloon was selected for a percutaneous transluminal angioplasty (pta) of shunt anastomosis.Successful dilation of the lesion was performed using the device.Vacuum was applied to remove from the patient.The balloon was not folded back into original position and was unable to be removed from the patient.One of the cutting balloon blades became stuck at the tip of the non-bsc 6f sheath.The balloon and sheath were surgically removed.The patient's status was fine.
 
Manufacturer Narrative
Device evaluated by mfr: a visual and microscopic examination was performed on the returned device.It was noted that approximately 4mm of the proximal end of one of the blades was lifted distally from the balloon material.The remaining 16mm 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 balloon and inflation lumen of the device were noted to have blood inside them which is evidence of a device leak.A microscopic examination identified a balloon pinhole located approximately 10mm distal of the proximal balloon sleeve.An examination of the balloon material and markerbands identified no issues.No issue was observed with the tip or markerbands of the device.A visual and tactile examination found the shaft of the device to be kinked at more than one location.This type of damage is consistent with excessive force being applied to the device.No other issues were identified during the product analysis.
 
Event Description
It was reported that the balloon failed to deflate and was difficult to remove.A 6.00mm/2.0cm/50cm peripheral cutting balloon was selected for a percutaneous transluminal angioplasty (pta) of shunt anastomosis.Successful dilation of the lesion was performed using the device.Vacuum was applied to remove from the patient.The balloon was not folded back into original position and was unable to be removed from the patient.One of the cutting balloon blades became stuck at the tip of the non-bsc 6f sheath.The balloon and sheath were surgically removed.The patient's status was fine.It was further reported that there was 70% stenosis and mild calcification of the shunt.
 
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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 Key10549051
MDR Text Key207398637
Report Number2134265-2020-12851
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 10/15/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received09/17/2020
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Expiration Date05/26/2022
Device Model Number24628
Device Catalogue Number24628
Device Lot Number0025536289
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer09/18/2020
Date Manufacturer Received09/25/2020
Patient Sequence Number1
Treatment
SHEATH: CORDIS 6FR; SHEATH: CORDIS 6FR; SHEATH: CORDIS 6FR
Patient Outcome(s) Required Intervention;
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