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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 M001PCB5020900
Device Problem Tear, Rip or Hole in Device Packaging (2385)
Patient Problem No Patient Involvement (2645)
Event Date 08/30/2017
Event Type  malfunction  
Manufacturer Narrative
Age at time of event: 18 years or older. The device was not returned for evaluation; therefore, no device analysis could be performed. A review of the manufacturing documentation found that all devices shipped from the batch conformed to the preventive measures / current controls as per the product specification. The most probable root cause is considered handling damage as the event occurred without direct patient contact. (b)(4).
 
Event Description
It was reported that there was a hole in the device package. A 2cm peripheral cutting balloon® was selected for use. During unpacking, it was noted that the sterile package had a hole. The procedure was completed with another of the same 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 Key6882183
MDR Text Key88250753
Report Number2134265-2017-09292
Device Sequence Number1
Product Code LIT
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K070951
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,health
Reporter Occupation
Type of Report Initial
Report Date 08/30/2017
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received09/21/2017
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date05/19/2019
Device Model NumberM001PCB5020900
Device Catalogue NumberPCB502090
Device Lot Number20665672
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 Received08/30/2017
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured06/22/2017
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

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