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

Model Number 45029

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Bradycardia (1751)

Event Date 10/22/2020

Event Type  Injury  

Manufacturer Narrative

Age at time of event: 18 years or older.

Event Description

It was reported that patient experienced bradycardia.The 100% stenosed, concentric and de novo target lesion was located in the left pulmonary artery.After a 6 fr guide catheter and 0.035 guidewire was inserted, an angiojet pe catheter was advanced for a thrombectomy procedure.The angiojet ultra console was then set to power pulse mode, however, it was noticed that blood was being lightly aspirated into the catheter line and collection bag.After under 20 seconds of use, the catheter was replaced with another angiojet pe catheter.Blood continued to be lightly aspirated during power pulse.No damage was observed with either catheter.It was noted that the patient experienced transient bradycardia and halted power pulse temporarily and within a few seconds bradycardia subsided.The physician thought that the bradycardia was related to the use of the angiojet device as it subsided when power pulse was stopped.The physician decided to proceed with the procedure and it was completed with technical and clinical success.No further patient complications were reported and patient's status was stable.

• Brand Name: ANGIOJET ULTRA PE
• Type of Device: CATHETER, EMBOLECTOMY
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; two scimed place; maple grove MN 55311
• Manufacturer (Section G): BOSTON SCIENTIFIC SCIMED, INC; two scimed place; maple grove MN 55311
• Manufacturer Contact: jay johnson ; two scimed place; maple grove, MN 55311 ; 7634942574
• MDR Report Key: 10823238
• MDR Text Key: 215885080
• Report Number: 2134265-2020-15633
• Device Sequence Number: 1
• Product Code: DXE
• Combination Product (y/n): N
• Reporter Country Code: AS
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 11/11/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 45029
• Device Catalogue Number: 45029
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 10/27/2020
• Initial Date FDA Received: 11/11/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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): Other