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

Model Number 45026

Device Problems Entrapment of Device (1212); Material Integrity Problem (2978)

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

Event Date 01/04/2024

Event Type  malfunction  

Event Description

It was reported that the catheter stuck, and tip frayed occurred.An angiojet avx catheter was advanced for a thrombectomy procedure.During the procedure, the physician noticed that the radiopaque markers were suddenly farther apart than normal.The device was pulled out to investigate, but the catheter was stuck and would not come back out of the sheath.It was stuck to the.035 non-boston scientific glidewire and could not get either of the device back out.The three devices had to be removed all together out of the patient at the same time.Once the physician had pulled the wire, the catheter and the sheath out together, a portion of the wire was still in the patient.They were able to free the catheter and sheath from the wire and inserted a new sheath to maintain access and was able to remove the wire.Moreover, it was noted that the catheter tip was frayed and mangled.The procedure was completed this device as they are far along in the case and had gotten enough clot out and did not need another catheter or product.No patient complications were reported.

Manufacturer Narrative

Device evaluated by mfr.: returned product consisted of an angiojet avx catheter.Media was returned in the form of a photo.The photo was reviewed which showed the tip damage which was confirmed during analysis.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 42 cm and 37.5 from proximal marker band.No guidewire was received with the device and no guidewire was inserted due to the extreme damage to the device.Functional testing was not attempted due to the extreme damage to the device.During analysis, damage was observed measuring from the proximal marker band at 1.5 cm to 4.5 cm, the entire section of the shaft was stretched with the hypotube detached and separated at 1.5 cm from the proximal marker band.Inspection of the remainder of the device, apart from the observed damage revealed no other damage or irregularities.

• Brand Name: ANGIOJET AVX
• Type of Device: CATHETER, EMBOLECTOMY
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 300 boston scientific way; marlborough MA 01752
• Manufacturer (Section G): BOSTON SCIENTIFIC CORPORATION; road 698, lot no. 12; dorado PR 00646 -260; * 00646-2602
• Manufacturer Contact: rachel shields ; 4100 hamline ave n; arden hills, MN 55112 ; 6512422111
• MDR Report Key: 18614530
• MDR Text Key: 334723840
• Report Number: 2124215-2024-05100
• Device Sequence Number: 1
• Product Code: DXE
• UDI-Device Identifier: 08714729889045
• UDI-Public: 08714729889045
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K133629
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 01/31/2024

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: 45026
• Device Catalogue Number: 45026
• Device Lot Number: 0032066769
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/22/2024
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 01/05/2024
• Initial Date FDA Received: 01/31/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/16/2023
• 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: 81 YR
• Patient Sex: Female
• Patient Weight: 76 KG
• Patient Race: White