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

Model Number 45031

Device Problems Entrapment of Device (1212); Material Deformation (2976)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 12/07/2022

Event Type  malfunction  

Event Description

It was reported that catheter stuck on wire.An angiojet solent omni catheter was selected for thrombectomy procedure.However, during the procedure, it was noticed that catheter could not advance further and stuck on guidewire.The unit was simply pulled out along with the guidewire however, and it got kinked.Another device was used to complete the procedure.There were no patient complications reported.

Manufacturer Narrative

G2: report source (other)- india added device evaluated by mfr: the product was returned to boston scientific for analysis.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 catheter shaft showed severe damage included multiple bends/kinks and buckling along shaft section located between 1 cm and 3.5 cm from the tip.The hypotube was also detached/separated at 1.5 cm from the tip.The device was received with no guidewire inside the device.A.035 guidewire was used to attempt to pass through the device which became stuck and would not pass through the shaft tip.Inspection of the remainder of the device, revealed no other damage or irregularities.The complaint was confirmed for guidewire issues related to severe shaft damage.

Event Description

It was reported that catheter stuck on wire.An angiojet solent omni catheter was selected for thrombectomy procedure.However, during the procedure, it was noticed that catheter could not advance further and stuck on guidewire.The unit was simply pulled out along with the guidewire however, and it got kinked.Another device was used to complete the procedure.There were no patient complications reported.

• Brand Name: ANGIOJET SOLENT OMNI
• Type of Device: CATHETER, EMBOLECTOMY
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 300 boston scientific way; marlborough MA 01752
• Manufacturer (Section G): BOSTON SCIENTIFIC CORPORATION; two scimed place; maple grove MN 55311
• Manufacturer Contact: rachel shields ; 4100 hamline ave n; arden hills, MN 55112 ; 6512422111
• MDR Report Key: 16015881
• MDR Text Key: 307988778
• Report Number: 2124215-2022-52072
• Device Sequence Number: 1
• Product Code: DXE
• Combination Product (y/n): N
• Reporter Country Code: IN
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Health Professional,Company Representative,Distributor
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 09/22/2023

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: 03/24/2024
• Device Model Number: 45031
• Device Catalogue Number: 45031
• Device Lot Number: 0029543867
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 12/07/2022
• Initial Date FDA Received: 12/20/2022
• Supplement Dates Manufacturer Received: 08/28/2023
• Supplement Dates FDA Received: 09/22/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/25/2022
• 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
• Patient Age: 63 YR
• Patient Sex: Male