MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION ANGIOJET® SPIROFLEX®; CATHETER, CORONARY, ATHERECTOMY

Model Number 106553-001

Device Problems Crack (1135); Leak/Splash (1354)

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

Event Date 11/04/2018

Event Type  malfunction  

Event Description

Angiojet spiroflex thrombectomy system was hooked up and when the bag of heparin was spiked, the nurse noticed that there was something leaking.After looking further, it was noticed that the tubing was cracked right at the hub where the spike is.Another one was used and worked fine (different lot number).

• Brand Name: ANGIOJET® SPIROFLEX®
• Type of Device: CATHETER, CORONARY, ATHERECTOMY
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 2 scimed place; maple grove MN 55311
• MDR Report Key: 8150196
• MDR Text Key: 129901386
• Report Number: 8150196
• Device Sequence Number: 1
• Product Code: MCX
• 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: 11/07/2018,11/05/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 106553-001
• Device Catalogue Number: 106553
• Device Lot Number: 22805003
• 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: 11/07/2018
• Event Location: Hospital
• Date Report to Manufacturer: 12/11/2018
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 12/11/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 25550 DA