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

Model Number 45026

Device Problem Device Difficult to Setup or Prepare (1487)

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

Event Date 09/06/2023

Event Type  malfunction  

Manufacturer Narrative

Device evaluated by mfr: the product was returned to boston scientific for analysis.Returned product consisted of an angiojet avx catheter.The catheter shaft showed multiple bends and kinks.The device was received stuck inside the introducer.There was shaft buckling 9 cm from the proximal marker band to the tip.Functional testing was not attempted due to the extreme damage.During analysis at the severely kinked location at 1.5 cm from the proximal marker band to the distal tip the hypotube was clearly broken and completely separated/missing.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 broken hypotube.Shaft kinks and buckling were also confirmed.Review of the product specification indicates the angiojet avx catheter is compatible with a 6 fr introducer sheath.The reported information indicates the angiojet avx catheter was used with a cordis avanti 6 fr introducer; therefore, there is no indication of a compatibility issue.

Event Description

Reportable based on the device analysis completed on (b)(6) 2023.It was reported that hypotube break occurred.An angiojet avx was selected for use in a thrombectomy procedure.However, during the preparation, the device failed to pump and prime.The procedure was completed with another of the same device.There were no patient complications reported.However, returned device analysis revealed a hypotube break and shaft buckling 9 cm from the proximal marker band to the tip.

• 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; two scimed place; maple grove MN 55311
• Manufacturer Contact: rachel shields ; 4100 hamline ave n; arden hills, MN 55112 ; 6512422111
• MDR Report Key: 18436734
• MDR Text Key: 331929877
• Report Number: 2124215-2023-74026
• 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: 01/03/2024

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: 0030659283
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/04/2023
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 12/13/2023
• Initial Date FDA Received: 01/03/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/12/2022
• 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