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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 Problems Inflation Problem (1310); Leak/Splash (1354)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 10/05/2021
Event Type  malfunction  
Manufacturer Narrative
(b)(6). Device evaluated by mfr. : a symmetry device was returned for analysis. A visual examination identified that the balloon was not folded which indicates that the device was subjected to positive pressure. The returned device was attached to a boston scientific encore inflation unit and positive pressure was applied; the balloon was inflated to its rate of burst pressure and a balloon pinhole leak on the surface of the distal balloon sleeve was identified. No other issues were identified with balloon inflation or the balloon material. No issues were identified with the tip of the device. A visual and microscopic examination found no issue with the markerbands. A visual and tactile examination found that the shaft was free from damage. No issues were noted which may have potentially contributed to the complaint incident.
 
Event Description
Reportable based on device analysis completed on 05-nov-2021. It was reported that tip leak and balloon inflation failure occurred. The 95% stenosed target lesion was located in an arteriovenous fistula in a mildly tortuous and mildly calcified vein side. A /6. 0-4/4t/90 symmetry balloon catheter was advanced for dilatation; however, during the first inflation, it was noticed thru fluoroscopy that the radiopaque substance was leaking near the tip part of the balloon and the pressure was unable to be applied. The procedure was completed with a different device. There were no patient injuries 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 Key12807257
MDR Text Key280944820
Report Number2134265-2021-14179
Device Sequence Number1
Product Code LIT
Combination Product (y/n)N
Reporter Country CodeJA
PMA/PMN Number
K143193
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Foreign,Health Professional,Company Representative,Distributor
Reporter Occupation
Type of Report Initial
Report Date 11/12/2021
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received11/12/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model Number23295
Device Catalogue Number23295
Device Lot Number0027290206
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer10/18/2021
Is the Reporter a Health Professional? Yes
Date Manufacturer Received11/05/2021
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured05/11/2021
Is the Device Single Use? Yes
Type of Device Usage Initial

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