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

Model Number 45027

Device Problems Difficult to Remove (1528); Detachment of Device or Device Component (2907); Difficult to Advance (2920)

Patient Problem No Code Available (3191)

Event Date 08/23/2018

Event Type  Injury  

Manufacturer Narrative

Age at time of event: older than 18 years.

Event Description

It was reported that the catheter became separated.An angiojet zelante catheter was selected for use for a venous thrombectomy procedure in the iliac and femoral veins.Upon inserting the zelante catheter into the non-bsc sheath and into the femoral vein of the patient, the device became stuck in the common femoral vein and separated/stretched.The physician attempted to move the device forward and backwards, and eventually it pulled apart.The physician then used a scalpel to make an incision into the patients groin and cut down to the femoral vein to remove the device.All parts of the device were retrieved from the patient.Another angiojet zelante catheter was used to complete the procedure.There were no patient complications reported and the patient's status post-procedure was fine.

Manufacturer Narrative

Age at time of event: older than 18 years.

Event Description

It was reported that the catheter became separated.An angiojet zelante catheter was selected for use for a venous thrombectomy procedure in the iliac and femoral veins.Upon inserting the zelante catheter into the non-bsc sheath and into the femoral vein of the patient, the device became stuck in the common femoral vein and separated/stretched.The physician attempted to move the device forward and backwards, and eventually it pulled apart.The physician then used a scalpel to make an incision into the patients groin and cut down to the femoral vein to remove the device.All parts of the device were retrieved from the patient.Another angiojet zelante catheter was used to complete the procedure.There were no patient complications reported and the patient's status post-procedure was fine.Device evaluated by mfr: blood was present outside and inside of the device, when received.Inspection of the device revealed that distal shaft was detached at the location where the proximal and distal shaft are connected (10cm proximal of the tip).The inner shaft was detached 103.Cm from the strain relief and the hypotube was detached at the jet body.The distal portion of the zelante catheter was received inside the returned introducer sheath with the tip sticking out of the sheath 3cm.The tip of the returned introducer sheath was damaged.The shaft was able to be removed from the introducer sheath with some resistance due to the damaged tip of the sheath.There was numerous kinks in the portion of the sheath that was inside of the introducer sheath.

• Brand Name: ANGIOJET ZELANTEDVT
• 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: sonali arangil ; two scimed place; maple grove, MN 55311 ; 6515827403
• MDR Report Key: 7860416
• MDR Text Key: 119691631
• Report Number: 2134265-2018-60832
• Device Sequence Number: 1
• Product Code: KRA
• UDI-Device Identifier: 08714729904724
• UDI-Public: 08714729904724
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K151313
• 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,Followup
• Report Date: 09/24/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 05/16/2020
• Device Model Number: 45027
• Device Catalogue Number: 45027
• Device Lot Number: 0022221769
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/07/2018
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 08/23/2018
• Initial Date FDA Received: 09/10/2018
• Supplement Dates Manufacturer Received: 09/16/2018
• Supplement Dates FDA Received: 09/24/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/17/2018
• 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: 8 FR TERUMO SHEATH
• Patient Outcome(s): Required Intervention