Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BOSTON SCIENTIFIC - GALWAY 2CM PERIPHERAL CUTTING BALLOON¿; CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINA
  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

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 No Consequences Or Impact To Patient (2199)
Event Date 01/18/2018
Event Type  malfunction  
Manufacturer Narrative
Age at time of event: 18 years or older.(b)(4).
 
Event Description
It was reported that the blade was found to be partially detached upon removal from the patient.A 6mm x 2cm x 50cm peripheral cutting balloon¿ was selected for use for a shunt percutaneous transluminal angioplasty procedure.After deflation of the balloon, slight resistance was encountered upon removal of the device from the body.Once the device was removed from the non-bsc sheath, outside of the patient's body, it was noted that the blade of the device was partially detached.Then when the physician touched the blade, it fully detached.The procedure was completed with another of the same device.No patient complications were reported.
 
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.A visual and microscopic examination was performed on the returned device.It was noted that a section of one of the blades, approximately 10mm in length had completely detached from the proximal end of the balloon material.This detached section of blade was also returned for analysis.The next section of blade measuring approximately 1mm in length was noted to have lifted from the balloon material.The entire pad underneath the damaged blade was intact and fully bonded to the balloon material.The remaining section of blade measuring 9mm in length was undamaged and fully bonded to the balloon material.The entire 2cm of blade was accounted for.The damage identified can potentially be a result of the resistance encountered during the advancement or withdrawal of the device.All other blades were intact and fully bonded to the balloon material.No issues were noted with the blades or pads that could have contributed to the complaint incident.A visual examination of the balloon noted that the balloon was unfolded which indicates it had been subjected to positive pressure.A microscopic examination identified no issues with the balloon material that could have contributed to the complaint incident.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 identified no damage or any issues along the length of the device.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 investigation conclusion is operational context as the product meets the design & manufacture specification but due to anatomical/procedural factors encountered during the procedure, performance was limited.(b)(4).
 
Event Description
It was reported that the blade was found to be partially detached upon removal from the patient.A 6mm x 2cm x 50cm peripheral cutting balloon¿ was selected for use for a shunt percutaneous transluminal angioplasty procedure.After deflation of the balloon, slight resistance was encountered upon removal of the device from the body.Once the device was removed from the non-bsc sheath, outside of the patient's body, it was noted that the blade of the device was partially detached.Then when the physician touched the blade, it fully detached.The procedure was completed with another of the same device.No patient complications were reported.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand Name
2CM PERIPHERAL CUTTING BALLOON¿
Type of Device
CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINA
Manufacturer (Section D)
BOSTON SCIENTIFIC - GALWAY
MDR Report Key7252087
MDR Text Key99806028
Report Number2134265-2018-00732
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 01/18/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received02/08/2018
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Expiration Date10/12/2019
Device Model NumberM001BP50620B0
Device Catalogue NumberBP506020B
Device Lot Number0021249087
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer01/23/2018
Date Manufacturer Received02/14/2018
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Treatment
INTRODUCER SHEATH: MEDIKIT ULTRA HIGH FLOW6F
-
-