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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 Leak/Splash (1354)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 10/29/2019
Event Type  Malfunction  
Manufacturer Narrative

(b)(6). Device evaluated by mfr. : a visual examination identified that the balloon was not folded which indicates that the balloon was subjected to positive pressure. The returned device was attached to a boston scientific encore inflation unit. Positive pressure was applied when liquid was observed to be leaking from a pinhole located approximately 6mm distal of the distal markerband in the distal balloon sleeve. An examination of the balloon material and markerbands identified no issues which could potentially have contributed to this complaint. No other issues were identified during the product analysis.

 
Event Description

Reportable based on device analysis completed on 28-nov-2019. It was reported that balloon leak occurred. The target lesion was located in the severely tortuous and mildly calcified vein. A 3. 0-4/4t/90 symmetry balloon catheter was advanced for dilation. However, the pressure did not increase during first inflation. Physician removed and checked the balloon, it was confirmed that a liquid leakage was seen in the tip side. The procedure was completed with another 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 Key9454040
MDR Text Key176230404
Report Number2134265-2019-15429
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 12/11/2019
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received12/11/2019
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 Number0022915598
Was Device Available For Evaluation? Device Returned To Manufacturer
Date Returned to Manufacturer11/19/2019
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received11/28/2019
Was Device Evaluated By Manufacturer? Yes
Date Device Manufactured11/09/2018
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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