MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION ANGIOJET¿ SOLENT¿ PROXI; CATHETER, CONTINUOUS FLUSH

Model Number 109676-001

Device Problem Therapeutic or Diagnostic Output Failure (3023)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 03/18/2020

Event Type  malfunction  

Event Description

While attempting to connect the pump set to the angiojet, the device failed to install and operate.After the third attempt, "alerted device failure", new product was opened.The faulty pump set was never in contact with or used on the patient.

• Brand Name: ANGIOJET¿ SOLENT¿ PROXI
• Type of Device: CATHETER, CONTINUOUS FLUSH
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 2 scimed place; maple grove MN 55311
• MDR Report Key: 9910033
• MDR Text Key: 185916968
• Report Number: 9910033
• Device Sequence Number: 1
• Product Code: KRA
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 03/20/2020

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: Other
• Device Model Number: 109676-001
• Device Catalogue Number: 109676-001
• Device Lot Number: 24972453
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 03/20/2020
• Event Location: Hospital
• Date Report to Manufacturer: 04/01/2020
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 04/01/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 26645 DA