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U.S. Department of Health and Human Services

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

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BOSTON SCIENTIFIC CORPORATION CHARGER CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINAL Back to Search Results
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Vascular Dissection (3160); No Code Available (3191)
Event Date 06/11/2020
Event Type  Injury  
Event Description
It was reported that a dissection occurred that may have been caused by the charger balloon, requiring additional intervention. A charger balloon dilatation catheter was selected for use in the superficial femoral artery (sfa). The anatomy was moderately tortuous at the transition from the femoral artery to the sfa with moderate calcification and 70% stenosis. A 0. 035" guidewire and a non-bsc 6f guide sheath were used in this procedure. While attempting to advance a 5mm x 60mm x 130cm innova stent to the proximal sfa, the distal edge of the stent caught on the proximal edge of a newly deployed 5mm x 150mm innova stent and failed to cross. The innova device was removed. No damage to either stent was observed. Percutaneous transluminal angioplasty (pta) was performed on the proximal edge of the previously deployed innova stent with the charger balloon. A dissection occurred that may been caused by the charger balloon or a laser. An angiogram was not taken between the use of the laser and pta to confirm the cause of the dissection. The 5mm x 60mm x 130cm innova stent was then re-inserted and again failed to cross the proximal edge of the previously deployed innova stent. The innova device was removed. A non-bsc stent was then selected for use and successfully crossed the stent to treat the proximal sfa stenosis. The dissection was treated by stenting, and no additional patient complications were reported.
 
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Brand NameCHARGER
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 Key10508021
MDR Text Key206152388
Report Number2134265-2020-12501
Device Sequence Number1
Product Code LIT
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K112697
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,health
Reporter Occupation
Type of Report Initial
Report Date 09/09/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received09/09/2020
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received08/21/2020
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
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: 09/09/2020 Patient Sequence Number: 1
Treatment
5MM X 150MM INNOVA STENT; 5MM X 60MM X 130CM INNOVA STENT; MEDTRONIC 5MM X 60MM PROTEGE STENT; TERUMO 6FR DESTINATION GUIDING SHEATH
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