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

Model Number 45031

Device Problems Break (1069); Material Perforation (2205)

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

Event Date 01/22/2024

Event Type  malfunction  

Event Description

It was reported that catheter perforation occurred.The target lesion was in the lower extremity vein.An angiojet solent omni catheter was selected for lower extremity venous thrombectomy procedure.After the device was primed and flushing was performed, it was noted that the guidewire pierced from the side of the catheter and the body of the device was broken, affecting normal use.The procedure was completed with another of the same device.No complications reported and the patient was stable.

Manufacturer Narrative

E1.Initial reporter facility name-(b)(6).

Manufacturer Narrative

Device evaluated by mfr: the device was returned for evaluation.The pump assembly, effluent/supply line, shaft, tip, and spike line were visually examined for damage or any irregularities.The catheter shaft showed multiple bends and kinks.During the disinfecting process by the lab assistants, it was noted the outer shaft was barely attached and unintentionally separated while wiping the device.Functional testing was not attempted due to the extreme damage to the device.During analysis, it was observed the shaft and hypotube were completely separated at 114 cm from the tip.Inspection of the remainder of the device, apart from the observed damage revealed no other damage or irregularities.The complaint was confirmed for under issues related to a hypotube and shaft separation.Shaft kinks were also confirmed.E1.Initial reporter facility name-(b)(6).

Event Description

It was reported that catheter perforation occurred.The target lesion was in the lower extremity vein.An angiojet solent omni catheter was selected for lower extremity venous thrombectomy procedure.After the device was primed and flushing was performed, it was noted that the guidewire pierced from the side of the catheter and the body of the device was broken, affecting normal use.The procedure was completed with another of the same device.No complications reported and the patient was stable.

• 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: 18677387
• MDR Text Key: 335023240
• Report Number: 2124215-2024-04073
• 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: Other,Foreign,Health Professional,Company Representative,Distributor
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 03/04/2024

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 Model Number: 45031
• Device Catalogue Number: 45031
• Device Lot Number: 0031491677
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 01/23/2024
• Initial Date FDA Received: 02/09/2024
• Supplement Dates Manufacturer Received: 02/16/2024
• Supplement Dates FDA Received: 03/04/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/29/2023
• 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: 60 YR
• Patient Sex: Male
• Patient Weight: 76 KG