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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 M001BP90520B0
Device Problem Device Contamination with Chemical or Other Material (2944)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 04/12/2017
Event Type  malfunction  
Manufacturer Narrative
Age at time of event: 18 years or older.(b)(4).
 
Event Description
It was reported that the sterility of the device was compromised.A 5.00mm x 2.0cm x 90cm peripheral cutting balloon¿ was selected for use.During unpacking when removing the folding tool, it was noticed that about 30cm of hair fell into the tray.Furthermore, it appeared that the hair was caught in the balloon and tool from the beginning because the length of the hair could not be considered to be a hair of the device operator.The device was not used and was retrieved together with the hair.The procedure was completed with another of the same device.No patient complications were reported.
 
Manufacturer Narrative
The device was returned for analysis.The device was received by the investigator after it underwent the decontamination process.The device had been removed from the packaging it had been returned in, decontaminated and then repackaged for analysis in the cis laboratory.The device was inspected for foreign material and no foreign matter was observed during analysis of the returned pcb device.No issues were identified with the returned device that may have contributed to the complaint incident.As the device underwent the decontamination process, it cannot be determined if the alleged foreign material was returned with the device for analysis.The pouch had already been opened prior to receipt at the investigation site.It cannot be determined where the alleged foreign material originated from; however, the production unit that manufactured and packaged the device were made aware of the issue.The manufacturing batch record review confirmed that the device met all material, assembly and performance specifications.The most probable root cause was unable to be determined.(b)(4).
 
Event Description
It was reported that the sterility of the device was compromised.A 5.00mm x 2.0cm x 90cm peripheral cutting balloon¿ was selected for use.During unpacking when removing the folding tool, it was noticed that about 30cm of hair fell into the tray.Furthermore, it appeared that the hair was caught in the balloon and tool from the beginning because the length of the hair could not be considered to be a hair of the device operator.The device was not used and was retrieved together with the hair.The procedure was completed with another of the same device.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 - GALWAY
Manufacturer (Section G)
BOSTON SCIENTIFIC - GALWAY
Manufacturer Contact
sonali arangil
one scimed place
maple grove, MN 55311
7634941700
MDR Report Key6533999
MDR Text Key74075604
Report Number2134265-2017-04160
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 Physician
Type of Report Initial,Followup
Report Date 04/12/2017
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received05/01/2017
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Expiration Date08/10/2018
Device Model NumberM001BP90520B0
Device Catalogue NumberBP905020B
Device Lot Number0019577398
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer04/19/2017
Is the Reporter a Health Professional? Yes
Date Manufacturer Received05/23/2017
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured09/12/2016
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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