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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 Device Dislodged or Dislocated (2923)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 04/05/2019
Event Type  malfunction  
Manufacturer Narrative
Age at time of event: 18 years or older.(b)(6).
 
Event Description
It was reported that blade was peeled off.The 90% stenosed target lesion was located in moderately tortuous left forearm shunt vein side.A 6.00mm/2.0cm/90cm peripheral cutting balloon was selected for use.During the procedure, the balloon was inflated once at 6-10atm for 15 seconds.Consequently, after dilatation of the target lesion, it was noted that a part of the blade was peeled off.The device was simply removed from the patient's body and the balloon was still intact after removal.No components of the device was left inside the patient's body.No patient complications were reported.
 
Manufacturer Narrative
Age at time of event: 18 years or older.(b)(6).Device evaluated by manufacturer: the device was returned for analysis.The recommended introducer sheath size for this device is a 6f as per 2cm peripheral cutting balloon.The sheath used by the customer was not returned for analysis.Functional analysis revealed the device could not advance through a 6fr boston scientific introducer sheath due to a partially lifted blade.A visual and microscopic examination was performed on the returned device.It was noted that approximately 11mm of one of the blades was lifted from the balloon material.The remaining 9mm of the lifted blade and the whole 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.All other blades were intact and fully bonded to the balloon material.A visual examination identified that the balloon was not folded, indicating the balloon was subjected to positive pressure.The returned device was attached to a boston scientific encore inflation unit and positive pressure was applied and the balloon was inflated to its rate of burst pressure of 10atm (atmospheres) without issue.A vacuum was then applied.The inflation device was verified at 10atm (atmospheres), before and after use with a calibrated pressure gauge.This inflation to rate of burst pressure of 10atm (atmospheres) was repeated three times with no leaks or drop in pressure noted.No issues were identified with balloon inflation or the balloon material.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.
 
Event Description
It was reported that blade was peeled off.The 90% stenosed target lesion was located in moderately tortuous left forearm shunt vein side.A 6.00mm/2.0cm/90cm peripheral cutting balloon was selected for use.During the procedure, the balloon was inflated once at 6-10atm for 15 seconds.Consequently, after dilatation of the target lesion, it was noted that a part of the blade was peeled off.The device was simply removed from the patient's body and the balloon was still intact after removal.No components of the device was left inside the patient's body.No patient complications were reported.
 
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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 Key8556751
MDR Text Key143400169
Report Number2134265-2019-04437
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
Report Date 05/23/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received04/26/2019
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Expiration Date10/29/2020
Device Model Number24630
Device Catalogue Number24630
Device Lot Number0022863561
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer04/23/2019
Date Manufacturer Received05/21/2019
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Treatment
GUIDEWIRE: CRUISE; GUIDEWIRE: CRUISE; INTRODUCER SHEATH: VAIVT ACE 6FR; INTRODUCER SHEATH: VAIVT ACE 6FR
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