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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BOSTON SCIENTIFIC - GALWAY 2CM PERIPHERAL CUTTING BALLOON¿; CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINA
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BOSTON SCIENTIFIC - GALWAY 2CM PERIPHERAL CUTTING BALLOON¿; CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINA Back to Search Results
Model Number M001BP50520B0
Device Problem Detachment Of Device Component (1104)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 06/01/2016
Event Type  malfunction  
Manufacturer Narrative
Age at time of event: 18 years or older.(b)(4).
 
Event Description
It was reported that blade detachment occurred.Vascular access was obtained via retrograde approach.The 95% stenosed target lesion was located in the severely calcified and moderately tortuous proximal anastomotic portion of forearm vein.A 5.00mm/2.0cm/50cm peripheral cutting balloon was selected for use.During the procedure, after insertion of a 6f/3cm non bsc introducer sheath, a 0.018x100cm non bsc guidewire was able to cross the target lesion without issue.Then a 5.00mm/2.0cm/50cm peripheral cutting balloon was used to dilate the lesion.The pressure and duration of the first inflation was 4 atm/30secs, 2nd inflation was at 6atm/30secs, 3rd inflation was at 8atm /30sec and 4th inflation was 9atm / 120sec+2atm/180sec.After the dilatation, the proximal part of one blade was found to be separated.Upon touching the device outside the patient, the blade broke in half.The procedure was completed with this device.No patient complications were reported and the patient's condition was good.
 
Manufacturer Narrative
Device evaluated by mfr.,eval summary attached, method codes, result codes, conclusion codes updated.Device evaluated by manufacturer: the device was returned for analysis.It was noted that the proximal portion of one of the blades had detached and was broken off the balloon as described by the customer.The detached portion that broke off outside the patient was not received in the evaluation lab for analysis therefore it was not possible to measure that portion.The total length of the blade was 20mm.The remaining portion attached to the balloon measured at 7mm.This infers that 13mm of the blade broke off the balloon.Microscopic examination of the remaining portion confirmed that there were no signs of blade fragmentation and the blade pad was still intact.A photograph of a broken blade was received for review; the image is consistent with the portion that was broken outside the patient after the device was removed from the patient.No other issues were identified during the product analysis.Examination of the remaining blades confirmed that the blades were fully bonded to the balloon and no damage was noted.No other issues were identified during the product analysis.The manufacturing batch record review confirmed that the device met all material, assembly and performance specifications.The most probable root cause is operational context as device performance was limited due to anatomical procedural factors.(b)(4).
 
Event Description
It was reported that blade detachment occurred.Vascular access was obtained via retrograde approach.The 95% stenosed target lesion was located in the severely calcified and moderately tortuous proximal anastomotic portion of forearm vein.A 5.00mm/2.0cm/50cm peripheral cutting balloon was selected for use.During the procedure, after insertion of a 6f/3cm non bsc introducer sheath, a 0.018x100cm non bsc guidewire was able to cross the target lesion without issue.Then a 5.00mm/2.0cm/50cm peripheral cutting balloon was used to dilate the lesion.The pressure and duration of the first inflation was 4 atm/30secs, 2nd inflation was at 6atm/30secs, 3rd inflation was at 8atm /30sec and 4th inflation was 9atm / 120sec+2atm/180sec.After the dilatation, the proximal part of one blade was found to be separated.Upon touching the device outside the patient, the blade broke in half.The procedure was completed with this device.No patient complications were reported and the patient's condition was good.
 
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Brand Name
2CM PERIPHERAL CUTTING BALLOON¿
Type of Device
CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINA
Manufacturer (Section D)
BOSTON SCIENTIFIC - GALWAY
Manufacturer (Section G)
BOSTON SCIENTIFIC - GALWAY
Manufacturer Contact
linda leimer
one scimed place
maple grove, MN 55311
7634941700
MDR Report Key5754751
MDR Text Key48311279
Report Number2134265-2016-05815
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
Reporter Occupation Physician
Type of Report Initial,Followup
Report Date 06/01/2016
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received06/28/2016
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Expiration Date02/16/2018
Device Model NumberM001BP50520B0
Device Catalogue NumberBP505020B
Device Lot Number18931789
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer06/06/2016
Is the Reporter a Health Professional? Yes
Date Manufacturer Received08/31/2016
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured03/14/2016
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
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