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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 H965SCH505160
Device Problem Contamination (1120)
Patient Problem No Patient Involvement (2645)
Event Date 12/09/2014
Event Type  malfunction  
Event Description
It was reported that balloon contamination occurred.They were unpacking the 8.0-40, 80 wanda¿ balloon to prepare for a percutaneous transluminal angioplasty (pta).While unpacking the device, it "jumped" out of the package and contacted an unsterile surface.The physician completed the procedure with another of the same device.There were no patient complications.
 
Manufacturer Narrative
(b)(4).
 
Manufacturer Narrative
Device evaluated by mfr: received for analysis was the device without any packaging.The balloon protector was received placed over the balloon.There was no evidence of any device use.The balloon protector was withdrawn and an examination of the balloon found no issues.No kinks or damage was noted along the entire length of the shaft.An examination of the hub section of the device identified no anomalies which could potentially have contributed to the complaint incident.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 balloon contamination occurred.They were unpacking the 8.0-40, 80 wanda¿ balloon to prepare for a percutaneous transluminal angioplasty (pta).While unpacking the device, it "jumped" out of the package and contacted an unsterile surface.The physician completed the procedure with another of the same device.There were no patient complications.This product is only ous approved but it is similar to an approved us device.
 
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Brand Name
WANDA?
Type of Device
CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINAL
Manufacturer (Section D)
BOSTON SCIENTIFIC - GALWAY
ballybrit business park
galway
Manufacturer (Section G)
BOSTON SCIENTIFIC - GALWAY
ballybrit business park
galway
Manufacturer Contact
linda leimer
one scimed place
maple grove, MN 55311
7634941700
MDR Report Key4393404
MDR Text Key5307026
Report Number2134265-2015-00034
Device Sequence Number1
Product Code LIT
Combination Product (y/n)N
PMA/PMN Number
SIMILAR
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Foreign,Health Professional,Company Representative
Reporter Occupation Physician
Type of Report Initial,Followup
Report Date 12/09/2014
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received01/07/2015
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Expiration Date04/11/2017
Device Model NumberH965SCH505160
Device Catalogue NumberSCH-50516
Device Lot Number0017358717
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer12/23/2014
Is the Reporter a Health Professional? Yes
Date Manufacturer Received03/10/2015
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured10/14/2014
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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