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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 Detachment of Device or Device Component (2907)
Patient Problems No Consequences Or Impact To Patient (2199); Device Embedded In Tissue or Plaque (3165)
Event Date 03/09/2020
Event Type  Injury  
Manufacturer Narrative
(b)(6).
 
Event Description
It was reported that a blade was missing.The 75% stenosed target lesion was located in the moderately tortuous cephalic vein.A 6.00mm/ 2.0cm/ 50cm peripheral cutting balloon was selected for use.During procedure, dilatation was performed twice at 10 atm around the cephalic vein anastomosis (the angle was gently/slowly applied).The device was simply removed since the lesion area was properly expanded.However, one out of the four blade was missing even if excessive force more than usual was not used.The procedure was completed with this device.There were no complications reported and there was no problem with the patient.
 
Event Description
It was reported that a blade was missing.The 75% stenosed target lesion was located in the moderately tortuous cephalic vein.A 6.00mm/ 2.0cm/ 50cm peripheral cutting balloon was selected for use.During procedure, dilatation was performed twice at 10 atm around the cephalic vein anastomosis (the angle was gently/slowly applied).The device was simply removed since the lesion area was properly expanded.However, one out of the four blade was missing even if excessive force more than usual was not used.The procedure was completed with this device.There were no complications reported and there was no problem with the patient.It was further reported that the blade was possibly left inside the patient's body as it was not found.
 
Manufacturer Narrative
E1.Initial reporter city:(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 one of the blades was completely detached from the balloon material.The damage identified is consistent with excessive force being applied when resistance is encountered during the withdrawal of the device.All other blades were intact and fully bonded to the balloon material.A visual examination identified the returned balloon were relaxed with evidence of inflation media in the balloon.A visual and microscopic examination identified no issues with the balloon material.The returned device was attached to an encore inflation unit.Positive pressure was applied, and the balloon was successfully inflated to its rate of burst pressure of 10 atmospheres with no leaks or drops in pressure noted.The pressure was held for 30 seconds, this was recorded with a digital timer.The inflation device was verified at 10 atmospheres, before and after use with a calibrated pressure gauge.The rated burst pressure for this device is 10 atmospheres as instructions for use.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 damage or kinks to the shaft of the device.No other issues were identified during the product analysis.
 
Manufacturer Narrative
E1: initial reporter city: (b)(6).
 
Event Description
It was reported that a blade was missing.The 75% stenosed target lesion was located in the moderately tortuous cephalic vein.A 6.00mm/ 2.0cm/ 50cm peripheral cutting balloon was selected for use.During procedure, dilatation was performed twice at 10 atm around the cephalic vein anastomosis (the angle was gently/slowly applied).The device was simply removed since the lesion area was properly expanded.However, one out of the four blade was missing even if excessive force more than usual was not used.The procedure was completed with this device.There were no complications reported and there was no problem with the patient.It was further reported that the blade was possibly left inside the patient's body as it was not found.
 
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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 Key9903123
MDR Text Key185944168
Report Number2134265-2020-04092
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,Followup
Report Date 05/11/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received03/31/2020
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Expiration Date12/05/2021
Device Model Number24628
Device Catalogue Number24628
Device Lot Number0024884443
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer03/25/2020
Date Manufacturer Received04/24/2020
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Treatment
GUIDEWIRE-RADIFOCUS 018; GUIDEWIRE-RADIFOCUS 018; GUIDEWIRE-RADIFOCUS 018; INFLATION DEVICE-GOODMAN; INFLATION DEVICE-GOODMAN; INFLATION DEVICE-GOODMAN; INTRODUCER SHEATH-7F3CM; INTRODUCER SHEATH-7F3CM; INTRODUCER SHEATH-7F3CM
Patient Outcome(s) Other;
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