MAUDE Adverse Event Report: SIRTEX WILMINGTON LLC SIR SPHERES Y-90 MICROSPHERES; YTTRIUM-90 RESIN MICROSPHERES

Model Number SIR-Y001

Device Problems Obstruction of Flow (2423); Physical Resistance/Sticking (4012)

Patient Problem Underdose (2542)

Event Date 09/13/2019

Event Type  Injury  

Event Description

During infusion resistance was met when contrast was injected to infuse sir-spheres into patient.Tubing disconnected from microcatheter and attempt is made to flush microcatheter which was again met with resistance.Microcatheter and guidewire were removed and new 2.9 french microcatheter was inserted.Case completed.This incident was not cause by sir-spheres, however as the result of this catheter clogging - 14.42 mci's was administered and 21.2 mci's were drawn.So only 68% of the dose was administered to patient.

• Brand Name: SIR SPHERES Y-90 MICROSPHERES
• Type of Device: YTTRIUM-90 RESIN MICROSPHERES
• Manufacturer (Section D): SIRTEX WILMINGTON LLC; 16 upon dr.; no. 2-4; wilmington MA 01887
• Manufacturer (Section G): SIRTEX WILMINGTON LLC; 16 upon dr.; no. 2-4; wilmington MA 01887
• Manufacturer Contact: rachel tserng ; 300 unicorn park dr.; woburn, MA 01801
• MDR Report Key: 9270716
• MDR Text Key: 164839356
• Report Number: 3005579300-2019-00007
• Device Sequence Number: 1
• Product Code: NAW
• UDI-Device Identifier: M425SIRY0010
• UDI-Public: M425SIRY0010
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P990065
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 11/01/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/03/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: SIR-Y001
• Device Catalogue Number: SIR-Y001
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/04/2019
• Was Device Evaluated by Manufacturer?: No
• 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