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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BOSTON SCIENTIFIC - GALWAY SYMMETRY¿ 40 CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINAL

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BOSTON SCIENTIFIC - GALWAY SYMMETRY¿ 40 CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINAL Back to Search Results
Model Number H7493918760400
Device Problems Bent (1059); Device Damaged Prior to Use (2284); Tip (3123)
Patient Problem No Patient Involvement (2645)
Event Date 01/31/2017
Event Type  Malfunction  
Manufacturer Narrative

Age at time of event: 18 years or older. (b)(4). Device evaluated by mfr: the device was received with the balloon protector free moving on the shaft. There was no evidence of any device use. An examination of the distal fold in the balloon and tip identified a solidified substance on the surface of the distal end of the balloon and tip. The balloon was sent for testing in order to try and determine the characteristic of the substance on the balloon. Fourier transform infrared radiation (ftir) spectra analysis of the complaint device confirmed a 61% match to bioslide (hydrophilic) from the test library. However, it is glidex, not bioslide which is coated on our devices. As a result the device was compared against a good sample symmetry device. This confirmed that it was an 80% match to glidex which is applied to the balloon. As a result of this being an 80% match to glidex which is colourless (100% expected), further analysis detected a number of other elements - silicon (si), calcium (ca) and chlorine (cl). Also a reference spectra on an uncontaminated section of the balloon without any foreign matter (fm) did not show any of these elements. This would suggest that these elements were introduced to the device after the balloon protector was removed. One possibility is that the physician was not satisfied with the balloon fold. As a result the physician tried to manually fold the balloon as instructed in the products directions for use. It was through this manipulation that the balloon came in contact with some foreign elements. No other issues were noted. There were no issues with the balloon folds. 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

Reportable based on device analysis completed on 14-apr-2017. It was reported that distal tip damage occurred. The 99% stenosed target lesion was located in a shunt in the moderately tortuous and moderately calcified vessel. A 6. 0-4/4t/40 symmetry¿ balloon catheter was selected for use. However, during unpacking of the device, the distal tip part got flared and it was also noted that the distal end of the balloon was not cleanly wrapped. The device was not used in the patient and the procedure was completed using a 90cm shaft symmetry¿ balloon catheter. No patient complications were reported and the patient's status was good. However, returned device analysis revealed presence of foreign matter.

 
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Brand NameSYMMETRY¿ 40
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 Key6541243
MDR Text Key74315536
Report Number2134265-2017-04204
Device Sequence Number1
Product Code LIT
Combination Product (Y/N)N
PMA/PMN NumberSIMILAR
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type COMPANY REPRESENTATIVE,DISTRI
Reporter Occupation
Type of Report Initial
Report Date 01/31/2017
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received05/03/2017
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device EXPIRATION Date01/21/2019
Device MODEL NumberH7493918760400
Device Catalogue Number39187-6040
Device LOT Number0018836300
Was Device Available For Evaluation? Device Returned To Manufacturer
Date Returned to Manufacturer02/16/2017
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received04/14/2017
Was Device Evaluated By Manufacturer? Yes
Date Device Manufactured01/29/2016
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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