MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION ANGIOJET ULTRA SYSTEM CONSOLE; CATHETER, CORONARY, ATHERECTOMY

Model Number 45038

Device Problems Reflux within Device (1522); Suction Problem (2170)

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

Event Date 09/08/2021

Event Type  malfunction  

Manufacturer Narrative

Initial reporter facility name: (b)(6).

Event Description

It was reported that loss of aspiration occurred.An angiojet ultra system console was used for thrombectomy procedure.During the procedure, there was blood flowing back noticed and the suction was weak.The procedure was completed with this device.There were no patient complications reported and the patient status was stable.

Manufacturer Narrative

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

Event Description

It was reported that loss of aspiration occurred.An angiojet ultra system console was used for thrombectomy procedure.During the procedure, there was blood flowing back noticed and the suction was weak.The procedure was completed with this device.There were no patient complications reported and the patient status was stable.It was further reported that the device continue to pump saline when aspiration was lost.

Manufacturer Narrative

E1: initial reporter facility name: (b)(6) hospital device evaluated by mfr.: the angiojet drawer was returned for analysis.The drawer was decontaminated.A visual inspection was done on the drawer, and it failed due to corrosion noted on the inside and the roller pump spring was defective.Then, a functional test was done on the drawer and it failed with drawer stalled that resulted poor suction.

Event Description

It was reported that loss of aspiration occurred.An angiojet ultra system console was used for thrombectomy procedure.During the procedure, there was blood flowing back noticed and the suction was weak.The procedure was completed with this device.There were no patient complications reported and the patient status was stable.It was further reported that the device continue to pump saline when aspiration was lost.

• Brand Name: ANGIOJET ULTRA SYSTEM CONSOLE
• Type of Device: CATHETER, CORONARY, ATHERECTOMY
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; two scimed place; maple grove MN 55311
• Manufacturer (Section G): BOSTON SCIENTIFIC CORPORATION; two scimed place; maple grove MN 55311
• Manufacturer Contact: jay johnson ; 4100 hamline ave n; arden hills, MN 55112 ; 6515810888
• MDR Report Key: 12547924
• MDR Text Key: 273816300
• Report Number: 2134265-2021-12185
• Device Sequence Number: 1
• Product Code: MCX
• Combination Product (y/n): N
• Reporter Country Code: CH
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date: 10/06/2022

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: 45038
• Device Catalogue Number: 45038
• Device Lot Number: U8671
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 09/10/2021
• Initial Date FDA Received: 09/29/2021
• Supplement Dates Manufacturer Received: 10/11/2021; 09/16/2022
• Supplement Dates FDA Received: 11/07/2021; 10/06/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 12/31/2015
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1