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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION SYMMETRY 40 CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINAL

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BOSTON SCIENTIFIC CORPORATION SYMMETRY 40 CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINAL Back to Search Results
Model Number 23295
Device Problems Difficult to Remove (1528); Detachment of Device or Device Component (2907); Material Integrity Problem (2978)
Patient Problem Insufficient Information (4580)
Event Date 03/16/2022
Event Type  Injury  
Event Description
It was reported that removal difficulty and device detachment occurred. The 99% stenosed target lesion was located in the severely tortuous and moderately calcified forearm vein. After a 5. 5fr non-boston scientific (bsc) sheath was placed and a non-bsc guidewire crossed the lesion, a 6. 0-4/4t/40 symmetry 40 balloon catheter was advanced for dilatation. However, when the balloon and the guidewire were attempted to be pulled out from the sheath, a resistance on the balloon was slightly felt. Echocardiogram revealed that the balloon was material was kinked, inverted to 180 degrees, and could not be removed from the sheath. The balloon and the guidewire were both maneuvered in an attempt to remove but it was unsuccessful. Subsequently, puncture was performed from the tip of the lesion where the a forceps was used in an attempt to move the balloon. However, it could not be performed and the balloon ruptured as it was damaged with forceps. The shaft came off when the balloon was again attempted to be pulled out from the sheath slightly harder. It was deemed medically impossible to collect the balloon so the patient's arm was incised and the damaged balloon was removed entirely. The procedure was completed and no further patient complications were reported.
 
Manufacturer Narrative
(b)(6).
 
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Brand NameSYMMETRY 40
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 Key14091627
MDR Text Key289175333
Report Number2134265-2022-04136
Device Sequence Number1
Product Code LIT
Combination Product (y/n)N
Reporter Country CodeJA
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,Followup
Report Date 05/18/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received04/13/2022
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Model Number23295
Device Catalogue Number23295
Device Lot Number0028493705
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer04/11/2022
Is the Reporter a Health Professional? Yes
Date Manufacturer Received04/27/2022
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured12/03/2021
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

Patient Treatment Data
Date Received: 04/13/2022 Patient Sequence Number: 1
Treatment
GUIDEWIRE: MEDIKIT 0.018INCH; SHEATH: MEDIKIT 5.5FR
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