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

Model Number 45031

Device Problems Difficult to Remove (1528); Detachment of Device or Device Component (2907); Adverse Event Without Identified Device or Use Problem (2993)

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

Event Date 12/24/2023

Event Type  Injury  

Manufacturer Narrative

E1 - initial reporter facility name: (b)(6) hospital (b)(6).

Event Description

It was reported that catheter was difficult to remove and the tip detached.The target lesion was located in the left arm arteriovenous graft.An angiojet solent omni was used for thrombectomy procedure.The catheter functioned normally for 30 seconds during the first antegrade run from the venous side to the arterial side.After the catheter had passed the graft at the arterial anastomosis, the physician then attempted to withdraw the solent omni catheter, but resistance was noted.The catheter could not be advanced or withdrawn smoothly.The catheter was removed forcedly, however, the tip detached.The detached component was removed using a snaring device.There were no patient complications reported and the patient was stable.

Event Description

It was reported that catheter was difficult to remove and the tip detached.The target lesion was located in the left arm arteriovenous graft.An angiojet solent omni was used for thrombectomy procedure.The catheter functioned normally for 30 seconds during the first antegrade run from the venous side to the arterial side.After the catheter had passed the graft at the arterial anastomosis, the physician then attempted to withdraw the solent omni catheter, but resistance was noted.The catheter could not be advanced or withdrawn smoothly.The catheter was removed forcedly, however, the tip detached.The detached component was removed using a snaring device.There were no patient complications reported and the patient was stable.

Manufacturer Narrative

E1 - initial reporter facility name: (b)(6).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 shaft kinks at 8.3 cm and 20 cm from the proximal marker band.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 2 cm, the entire jet head and tip were detached/separated.The device could not be functionally tested due to the extreme damage on the device.No pressure reading 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 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: 18527391
• MDR Text Key: 333047117
• Report Number: 2124215-2023-76058
• Device Sequence Number: 1
• Product Code: DXE
• Combination Product (y/n): N
• Reporter Country Code: HK
• 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
• Report Date: 02/13/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/17/2024
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 45031
• Device Catalogue Number: 45031
• Device Lot Number: 0031556585
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/24/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/20/2023
• 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 Outcome(s): Required Intervention