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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 M001BP50620B0
Device Problem Detachment Of Device Component (1104)
Patient Problem Device Embedded In Tissue or Plaque (3165)
Event Date 04/15/2017
Event Type  Injury  
Manufacturer Narrative
Age at time of event: 18 years or older. (b)(4). Device evaluated by mfr. : device was not returned for 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 the blade could not be found. The 90% stenosed target lesion was located in the mildly tortuous and mildly calcified forearm vein. A 6. 00 mm/ 2. 0 cm/ 50 cm peripheral cutting balloon¿ was selected for use. During the procedure, the device was inserted inside the sheath but slight resistance was observed. When the device was removed after inflation, it was noted that the blade could not be found. Although the stenosis area was dilated, still it was unable to confirm whether the blade is inside or outside the patient's body but it was probable that the blade was detached when the device was inserted into the sheath. The procedure was completed with this device. No patient complications were reported.
 
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Brand Name2CM PERIPHERAL CUTTING BALLOON¿
Type of DeviceCATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINA
Manufacturer (Section D)
BOSTON SCIENTIFIC - GALWAY
Manufacturer (Section G)
BOSTON SCIENTIFIC - GALWAY
Manufacturer Contact
sonali arangil
one scimed place
maple grove, MN 55311
7634941700
MDR Report Key6571746
MDR Text Key75322326
Report Number2134265-2017-04490
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
Reporter Occupation
Type of Report Initial
Report Date 04/19/2017
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received05/17/2017
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date01/16/2019
Device Model NumberM001BP50620B0
Device Catalogue NumberBP506020B
Device Lot Number0020168320
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received04/19/2017
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured02/13/2017
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

Patient Treatment Data
Date Received: 05/17/2017 Patient Sequence Number: 1
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