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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BOSTON SCIENTIFIC - GALWAY WANDA¿ CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINAL

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BOSTON SCIENTIFIC - GALWAY WANDA¿ CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINAL Back to Search Results
Model Number H965SCH505110
Device Problem Contamination /Decontamination Problem (2895)
Patient Problem No Patient Involvement (2645)
Event Date 03/13/2017
Event Type  malfunction  
Manufacturer Narrative
(b)(4).
 
Event Description
It was reported that the device became contaminated during unpacking. During unpacking of a 6. 0-80, 80 (b)(6) balloon catheter, when the box was opened, 'the balloon exited immediately' from the package and it was desterilized. No patient complications were reported.
 
Manufacturer Narrative
Device evaluated by mfr. Received for analysis was the outer box, inner packaging and the wanda balloon catheter. The outer box was torn open. No other damage was present. The wanda device was free moving in the opened inner packaging. The inner tray was not returned for analysis. An examination of the balloon catheter identified no issues. There was no evidence of any device use. The manufacturing batch record review confirmed that the device met all material, assembly and performance specifications. 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 the device became contaminated during unpacking. During unpacking of a 6. 0-80, 80 wanda balloon catheter, when the box was opened, 'the balloon exited immediately' from the package and it was desterilized. No patient complications were reported.
 
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Brand NameWANDA¿
Type of DeviceCATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINAL
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 Key6483143
MDR Text Key72511067
Report Number2134265-2017-03766
Device Sequence Number1
Product Code LIT
Combination Product (y/n)N
Reporter Country CodeBE
PMA/PMN Number
SIMILAR
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Reporter Occupation
Type of Report Initial,Followup
Report Date 03/22/2017
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received04/11/2017
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date07/08/2019
Device Model NumberH965SCH505110
Device Catalogue NumberSCH-50511
Device Lot Number20131604
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer04/07/2017
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received05/03/2017
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured01/13/2017
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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