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

Model Number 45030

Device Problems Difficult to Advance (2920); Mechanical Jam (2983)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 08/11/2020

Event Type  malfunction  

Manufacturer Narrative

Device evaluated by mfr.: returned product consisted of a solent dista thrombectomy system.The pump assembly, effluent/supply line, shaft, tip, and spike line were microscopically and visually inspected.Blood was present inside the device and the waste bag was cut-off, when received.Inspection of the device revealed that there were numerous kinks throughout the shaft, with the shaft twisted 34cm distal of the strain relief and 23cm - 25cm proximal from the tip.The shaft also had damage that was consistent to a guidewire being pushed into the shaft from the inside 25cm proximal of the tip.The hypotube was found to be separated at the same location 25cm proximal of the tip.The tip was also damaged.The id (inner diameter) of the hub and tip was measured and was within specification.A test guidewire was used for functional testing and the wire was able to be inserted into the tip and advanced; however, the wire met resistance when trying to pass through the catheter due to the damage to the shaft of the device.

Event Description

Reportable based on device analysis completed on 22sep2020.It was reported that guidewire restriction occurred.The target lesions were located in the tibial arteries.After inserting a 0.014 pt2 guidewire, an angiojet solent dista catheter was advanced for treatment.During the procedure, after flushing the catheter well, power pulse spray was done with actyleaze along the segment from popliteal and posterior tibial artery and left for 50 minutes.The procedure was continued, however, some resistance in the wire movement inside the catheter was encountered and suddenly it stuck in the catheter.The devices were removed together and then the catheter was removed from the wire outside the patient's body.An angiojet solent omni catheter was used on the same pt2 wire and the procedure was completed.No patient complications were reported and the patient's status was stable.However, returned device analysis revealed a hypotube break.

• 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 CORPORATION; 500 commander shea boulevard; quincy MA 02171
• Manufacturer Contact: jay johnson ; two scimed place; maple grove, MN 55311 ; 7634942574
• MDR Report Key: 10635129
• MDR Text Key: 209996119
• Report Number: 2134265-2020-13749
• Device Sequence Number: 1
• Product Code: DXE
• Combination Product (y/n): N
• Reporter Country Code: EG
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,distri
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 10/06/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/06/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 02/17/2021
• Device Model Number: 45030
• Device Catalogue Number: 45030
• Device Lot Number: 0023613330
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/15/2020
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 09/22/2020
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/21/2019
• 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: 0.014 PT2 GUIDEWIRE
• Patient Age: 60 YR
• Patient Weight: 70