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

Model Number 45031

Device Problems Adverse Event Without Identified Device or Use Problem (2993); Pumping Problem (3016)

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

Event Date 04/04/2022

Event Type  malfunction  

Event Description

Reportable based on device analysis completed on 02aug2022.It was reported that pump seal fault occurred.The target lesion was located in the right lower limb vein.A angiojet solent omni was selected for use.During throbectomy mode, a liquid was noted in the pump.The procedure was completed with another of the same device.There were no patient complications were reported and the patient's status is stable.However, returned device analysis revealed hypotube detachment.

Manufacturer Narrative

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 catheter shaft showed multiple kinks and showed 1 severe kink located 100cm from the tip.Functional testing was attempted; however, the device would not prime.During analysis at the severely kinked location (100cm) the hypotube was clearly broken open and completely separated.The device could not be functionally tested due to the extreme damage on the device.A pressure reading of 1.461 was reported before the console would stop the priming process and issue an under-pressure alarm.Inspection of the remainder of the device, apart from the observed damage revealed no other damage or irregularities.The complaint was confirmed for under pressure issues related to a broken hypotube.The kinks were also confirmed.

• Brand Name: ANGIOJET SOLENT OMNI
• Type of Device: CATHETER, EMBOLECTOMY
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; two scimed place; maple grove MN 55311
• Manufacturer (Section G): BOSTON SCIENTIFIC CORPORATION; two scimed place; maple grove MN 55311
• Manufacturer Contact: jay johnson ; 4100 hamline ave n; arden hills, MN 55112 ; 6515810888
• MDR Report Key: 15279163
• MDR Text Key: 304996428
• Report Number: 2134265-2022-08625
• Device Sequence Number: 1
• Product Code: DXE
• Combination Product (y/n): N
• Reporter Country Code: CH
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative,Distributor
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 08/23/2022

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: 11/09/2023
• Device Model Number: 45031
• Device Catalogue Number: 45031
• Device Lot Number: 0028613644
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/12/2022
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 08/02/2022
• Initial Date FDA Received: 08/23/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/10/2021
• 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: 71 YR
• Patient Sex: Female
• Patient Weight: 55 KG