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

Model Number 45031

Device Problems Break (1069); Adverse Event Without Identified Device or Use Problem (2993)

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

Event Date 12/16/2023

Event Type  malfunction  

Manufacturer Narrative

E1: initial reporter city: (b)(6).

Event Description

It was reported that tip break occurred.The 70% stenosed target lesion was located in the straight tortuosity and severely calcified right lower extremity vessel.An angiojet solent omni was selected for use for thrombectomy procedure.During the procedure, the device was introduced into the blood vessel for approximately 5 to 6 seconds, encountering resistance, and upon removal, it was observed that the tip bifurcated.The device was removed without any problem, and the procedure was completed with a similar device.There were no patient complications reported, and the patient was in good condition after the procedure.

Event Description

It was reported that tip break occurred.The 70% stenosed target lesion was located in the straight tortuosity and severely calcified right lower extremity vessel.An angiojet solent omni was selected for use for thrombectomy procedure.During the procedure, the device was introduced into the blood vessel for approximately 5 to 6 seconds, encountering resistance, and upon removal, it was observed that the tip bifurcated.The device was removed without any problem, and the procedure was completed with a similar device.There were no patient complications reported, and the patient was in good condition after the procedure.

Manufacturer Narrative

E1: initial reporter city: (b)(6).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 bends and kinks.Functional testing was attempted; however, the device would not prime.During analysis, damage was observed measuring from the proximal marker band to the tip at 1.5 cm, the entire jet head/tip were detached/separated and missing from the device.The device could not be functionally tested due to the extreme damage on the device.Inspection of the remainder of the device, apart from the observed damage revealed no other damage or irregularities.The complaint was confirmed for issues related to a detached tip.Kinks were also confirmed.

• 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: 18521657
• MDR Text Key: 332978760
• Report Number: 2124215-2023-76005
• 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: 02/16/2024

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: 0031315826
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 12/18/2023
• Initial Date FDA Received: 01/16/2024
• Supplement Dates Manufacturer Received: 01/26/2024
• Supplement Dates FDA Received: 02/16/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/08/2023
• 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: 46 YR
• Patient Sex: Female
• Patient Weight: 70 KG