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

Model Number 45031

Device Problem Device Contamination with Chemical or Other Material (2944)

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

Event Date 01/18/2022

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

It was reported that a foreign matter was present at the tip.The 100% stenosed target lesion was located in the mildly tortuous and severely calcified femoral iliac vein.An angiojet solent omni was selected for use in a thrombectomy procedure.During the preparation, it was noted that priming was weaker than usual.After priming, the guidewire was advanced but it could not cross the catheter.The tip of the catheter was occluded by a white foreign matter.The procedure was completed with another of the same device.There were no patient complications reported and patient's status was stable.

Manufacturer Narrative

H1 - initial reporter facility name: (b)(6) hospital.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 device showed 2 kinks located 39.5cm and 68cm from the tip.The device tip was microscopically examined for any foreign material.No foreign material was noticed.A.035 test amplatz guidewire was inserted into the lumen of the device.The wire transcended through the device with a slight restriction; however, the wire did pass through the entire device.Functional testing was completed per device preparation.The pump was inserted into the ultra drive unit console.The pump and device primed, and the device was run for a period of 90 seconds in the thrombectomy mode.The devices pressure was within the normal range.Inspection of the remainder of the device, apart from the observed damage revealed no other damage or irregularities.

Event Description

It was reported that a foreign matter was present at the tip.The 100% stenosed target lesion was located in the mildly tortuous and severely calcified femoral iliac vein.An angiojet solent omni was selected for use in a thrombectomy procedure.During the preparation, it was noted that priming was weaker than usual.After priming, the guidewire was advanced but it could not cross the catheter.The tip of the catheter was occluded by a white foreign matter.The procedure was completed with another of the same device.There were no patient complications 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
• Manufacturer (Section G): BOSTON SCIENTIFIC CORPORATION; two scimed place; maple grove MN 55311
• Manufacturer Contact: jay johnson ; two scimed place; maple grove, MN 55311 ; 7634942574
• MDR Report Key: 13840902
• MDR Text Key: 287582171
• Report Number: 2134265-2022-03115
• 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,Followup
• Report Date: 04/22/2022

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: 05/31/2023
• Device Model Number: 45031
• Device Catalogue Number: 45031
• Device Lot Number: 0027700468
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 02/24/2022
• Initial Date FDA Received: 03/21/2022
• Supplement Dates Manufacturer Received: 04/01/2022
• Supplement Dates FDA Received: 04/23/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/01/2021
• 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: 51 YR
• Patient Sex: Male
• Patient Weight: 80 KG