MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION ANGIOJET SOLENT DISTA; CATHETER, EMBOLECTOMY

Model Number 45030

Device Problem Material Perforation (2205)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 06/04/2019

Event Type  malfunction  

Manufacturer Narrative

The returned product consisted of a solent dista thrombectomy catheter.The pump, effluent/supply line, shaft, tip, piston, and spike line were visually inspected.Blood was present outside and inside the device and 50ml in the attached waste bag, when received.Visual inspection of the device revealed that the shaft was twisted/kinked 30cm from the strain relief and that the shaft was detached 26cm proximal of the tip at the proximal and distal shaft transition.Microscopic examination revealed that there was a hole at the twisted/kinked location and the distal end that was detached was stretched with jagged edges.The damage to the both damaged areas indicates that there was force applied to the device during use.Functional testing was performed placing a test guidewire into the tip and advancing the device; however, there was resistance at the separated ends and it won't pass the twisted/kinked shaft after it passed the separated shaft.Inspection of the remainder of the device presented no other damage or irregularities.

Event Description

Reportable based off on analysis completed on 7 july 2019.It was reported that the wire perforated the catheter wall outside the patient.An angiojet solent dista catheter was selected for a procedure in the patient's leg.The staff primed the catheter as usual, but when they inserted the wire into the catheter, they found that the wire came out of the side of the catheter.It appeared that the wire perforated the catheter wall and came out on the side of the shaft as if it were a rapid exchange device.This issue occurred outside of the patient.Another of the same device was used to complete the procedure.No patient complications were reported.The patient condition after the procedure was fine.However, device analysis revealed a detached shaft.

• Brand Name: ANGIOJET SOLENT DISTA
• Type of Device: CATHETER, EMBOLECTOMY
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; two scimed place; maple grove MN 55311
• Manufacturer (Section G): BOSTON SCIENTIFIC SCIMED, INC; two scimed place; maple grove MN 55311
• Manufacturer Contact: jay johnson ; two scimed place; maple grove, MN 55311 ; 7634942574
• MDR Report Key: 8826142
• MDR Text Key: 152194976
• Report Number: 2134265-2019-08704
• Device Sequence Number: 1
• Product Code: DXE
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: K113363
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 07/25/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 10/10/2019
• Device Model Number: 45030
• Device Catalogue Number: 45030
• Device Lot Number: 0021485228
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/01/2019
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 07/07/2019
• Initial Date FDA Received: 07/25/2019
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/10/2017
• 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