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

Model Number 45031

Device Problems Entrapment of Device (1212); Mechanical Jam (2983)

Patient Problems No Consequences Or Impact To Patient (2199); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 01/05/2021

Event Type  malfunction  

Manufacturer Narrative

Initial reporter facility name - (b)(4).

Event Description

It was reported that catheter stuck on guidewire occurred.The target lesion was located in the left lower extremity deep vein.An angiojet solent omni was advanced for a thrombectomy procedure.During procedure under thrombectomy mode for 62 seconds, it was noted that a non-bsc guidewire was stuck on the catheter and could not be advanced or withdrew.The physician withdrew the guidewire with force and stopped thrombectomy.The guidewire was found curved.Another non-bsc guidewire was advanced but failed as well.The procedure was completed with another of the same device.No patient complications were reported and patient's status was stable.

Manufacturer Narrative

E1: initial reporter facility name - (b)(6) hospital.D4: lot number - updated to 25644208.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 kink located 92.5cm from the tip.The pump and catheter were primed, and the device was run for a period of 120 seconds in the thrombectomy mode.The devices pressure was within the normal range.Power pulse mode was activated, and the device functioned as designed.A.035 test guidewire was inserted into the catheter from the tip and transcended through the device with a slight restriction at the kinked area of the catheter shaft; however, the guidewire transcended through the entire catheter shaft.Inspection of the remainder of the device, apart from the observed damage revealed no other damage or irregularities.

Event Description

It was reported that catheter stuck on guidewire occurred.The target lesion was located in the left lower extremity deep vein.An angiojet solent omni was advanced for a thrombectomy procedure.During procedure under thrombectomy mode for 62 seconds, it was noted that a non-bsc guidewire was stuck on the catheter and could not be advanced or withdrew.The physician withrew the guidewire with force and stopped thrombectomy.The guidewire was found curved.Another non-bsc guidewire was advanced but failed as well.The procedure was completed with another of the same device.No patient complications were reported and patient's status was stable.

• 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: 11208322
• MDR Text Key: 228008089
• Report Number: 2134265-2021-00538
• 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

• Date FDA Received: 01/21/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 05/05/2022
• Device Model Number: 45031
• Device Catalogue Number: 45031
• Device Lot Number: 0025644208
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/26/2021
• Date Manufacturer Received: 02/01/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 65 YR
• Patient Weight: 60