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

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.

• Brand Name: CHARGER
• Type of Device: CATHETER, 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 Key: 10508021
• MDR Text Key: 206152388
• Report Number: 2134265-2020-12501
• Device Sequence Number: 1
• Product Code: LIT
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K112697
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Physician
• 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 Received: 09/09/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/21/2020
• 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 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
• Patient Outcome(s): Other; Required Intervention