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

Model Number 45031

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Bradycardia (1751); Chest Pain (1776); Emotional Changes (1831); Low Blood Pressure/ Hypotension (1914); Pain (1994); Chest Tightness/Pressure (2463); Embolism/Embolus (4438)

Event Date 12/18/2020

Event Type  Injury  

Manufacturer Narrative

Initial reporter facility name: (b)(6).

Event Description

It was reported that patient became manic, had back pain, chest tightness, hypotension and bradycardia.The 90% stenosed, non-tortuous target lesion was located in the deep vein of right lower extremity, with implanted filter.An angiojet solent omni catheter was used for a thrombectomy procedure.During the procedure, the patient suddenly became manic, felt chest tightness and had back pain.The physical signs showed a rapid decrease in oxygen saturation to 80%, heart rate was more than 40 and blood pressure dropped from 135/80 to 80/60.Emergency treatment was performed and a multidisciplinary consultation was held.The patient was finally sent to the intensive care unit for monitoring.No further patient complications were reported and patient's status was stable.

Event Description

It was reported that patient became manic, had back pain, chest tightness, hypotension and bradycardia.The 90% stenosed, non-tortuous target lesion was located in the deep vein of right lower extremity, with implanted filter.An angiojet solent omni catheter was used for a thrombectomy procedure.During the procedure, the patient suddenly became manic, felt chest tightness and had back pain.The physical signs showed a rapid decrease in oxygen saturation to 80%, heart rate was more than 40 and blood pressure dropped from 135/80 to 80/60.Emergency treatment was performed and a multidisciplinary consultation was held.The patient was finally sent to the intensive care unit for monitoring.No further patient complications were reported and patient's status was stable.It was further reported that as per physician, the patient decompensating is not related with the use and quality of the device and also speculated that it may be caused by the micro embolus flowing inside the patient lung while treating the patient's thrombosis.The emergency treatment that was provided to the patient was drug therapy.

Manufacturer Narrative

E1: initial reporter facility name - (b)(6).D4: lot number - updated to 25536713.Device evaluated by mfr: returned product consisted of an angiojet solent omni catheter.The pump assembly, effluent/supply line, shaft, tip and spike line were visually examined for damage or any irregularities.The shaft showed a slight pin hole in the pebax of the shaft located 7cm from the tip.Functional testing was attempted per the device preparation.The pump was inserted into the ultra drive unit console.The pump and catheter would not prime.The shaft was looked at under microscopic inspection and it was noticed that there was a hole in the hypotube which leaked fluid and caused the device not to prime.The device pressure was below the normal range.Inspection of the remainder of the device, apart from the observed damage revealed no other damage or irregularities.

• Brand Name: ANGIOJET SOLENT OMNI
• Type of Device: CATHETER, EMBOLECTOMY
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; two scimed place; maple grove MN 55311
• MDR Report Key: 11172757
• MDR Text Key: 226895887
• Report Number: 2134265-2021-00264
• Device Sequence Number: 1
• Product Code: DXE
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,distri
• Type of Report: Initial,Followup
• Report Date: 02/22/2021

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?: No
• Device Operator: Health Professional
• Device Expiration Date: 03/31/2022
• Device Model Number: 45031
• Device Catalogue Number: 45031
• Device Lot Number: 0025536713
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/26/2021
• Initial Date Manufacturer Received: 01/06/2021
• Initial Date FDA Received: 01/14/2021
• Supplement Dates Manufacturer Received: 02/01/2021
• Supplement Dates FDA Received: 02/22/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 78 YR