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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION SYMMETRY CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINAL

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BOSTON SCIENTIFIC CORPORATION SYMMETRY CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINAL Back to Search Results
Model Number 23295
Device Problem Material Deformation (2976)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 09/27/2019
Event Type  Malfunction  
Manufacturer Narrative

Device evaluated by mfr. : the customer's guidewire was not returned for analysis. A visual and tactile examination of the shaft identified one severe kink approximately 95mm from the balloon bond. During analysis the investigator selected a 0. 018 inch guidewire, the guidewire was inserted through the device, however minor resistance was encountered at the location of the shaft kink. This type of damage is consistent with excessive force being applied to the device. A visual examination identified that there was blood in the balloon material which suggests that there is a leak in the device. The returned device was attached to an encore inflation unit and positive pressure was applied in an attempt to inflate the balloon. The balloon could not be inflated due to the presence of solidified blood that was present within the inflation lumen. The device was soaked in a water bath at a temperature of 37 degrees celsius to help soften the blood before further inflation attempts were made. The device was removed from the bath and the balloon was again attached to an inflation device subjected to positive pressure and liquid was observed to be leaking from a balloon pinhole located at the distal edge of the distal markerband. An examination of the balloon material and markerbands identified no issues which could potentially have contributed to this complaint. An examination of the markerbands and tip identified no damage or any issues that could have potentially contributed to the complaint incident. No other issues were identified during the product analysis.

 
Event Description

Reportable based on device analysis completed on 15nov2019. It was reported that crossing difficulties were encountered and shaft kink occurred. The target lesion was 90% stenosed and locate in the severely calcified and moderately tortuous vessel. A 3. 5-4/4t/90 symmetry balloon catheter was advanced but failed to cross the lesion. The physician pushed the device but the catheter got kinked. The procedure was completed with another of the same device. There were no patient complications reported. However, returned device analysis revealed balloon pinhole.

 
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Brand NameSYMMETRY
Type of DeviceCATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINAL
Manufacturer (Section D)
BOSTON SCIENTIFIC CORPORATION
two scimed place
maple grove MN 55311
Manufacturer (Section G)
BOSTON SCIENTIFIC CORPORATION
ballybrit business park
galway
EI
Manufacturer Contact
jay johnson
two scimed place
maple grove, MN 55311
7634942574
MDR Report Key9412405
MDR Text Key173645375
Report Number2134265-2019-14941
Device Sequence Number1
Product Code LIT
Combination Product (Y/N)N
Reporter Country CodeJA
PMA/PMN NumberK143193
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 12/04/2019
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received12/04/2019
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device MODEL Number23295
Device Catalogue Number23295
Device LOT Number0023700384
Was Device Available For Evaluation? Device Returned To Manufacturer
Date Returned to Manufacturer10/22/2019
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received11/15/2019
Was Device Evaluated By Manufacturer? Yes
Date Device Manufactured04/26/2019
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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