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

Model Number 45029

Device Problems Display or Visual Feedback Problem (1184); Leak/Splash (1354)

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

Event Date 05/08/2023

Event Type  malfunction  

Event Description

Reportable based on device analysis completed on (b)(6) 2023.It was reported that the system alerted an error, and a tube leak occurred.An angiojet ultra pe was selected for used for thrombectomy procedure.During the procedure, it was observed that there was an infusion error during the initiation of the first three pulses.Additionally, there was a catheter connection leakage, prompting a message to change the device.The procedure was completed with a different device.There were no patient complications reported.However, returned device analysis revealed a catheter shaft kink/fracture.

Manufacturer Narrative

Device evaluated by mfr: the product was returned to boston scientific for analysis.Returned product consisted of an angiojet pe catheter.The photo was reviewed which showed the alleged leak and was confirmed during analysis.The catheter shaft showed a kink/fracture at 73 cm from the tip.Functional testing was completed per the ifu device preparation.During functional testing no errors or priming issues were noticed, the device ran as designed.During functional testing there was a leak at the male luer connector.During functional testing no errors or priming issues were noticed, the device ran as designed.Inspection of the remainder of the device, apart from the observed damage revealed no other damage or irregularities.The complaint was not confirmed for set up issues and alarms.The device was confirmed the male luer connector leak and a shaft kink/fracture.

• Brand Name: ANGIOJET ULTRA PE
• 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: 18075533
• MDR Text Key: 328486193
• Report Number: 2124215-2023-62080
• Device Sequence Number: 1
• Product Code: DXE
• Combination Product (y/n): N
• Reporter Country Code: BR
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 11/06/2023

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 Expiration Date: 05/28/2023
• Device Model Number: 45029
• Device Catalogue Number: 45029
• Device Lot Number: 0027911053
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/13/2023
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 10/17/2023
• Initial Date FDA Received: 11/06/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/28/2021
• 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