MAUDE Adverse Event Report: SUREFIRE MEDICAL, INC. SUREFIRE PRECISION INFUSION SYSTEM; INTRAVASCULAR DIAGNOSTIC CATHETER

Catalog Number SPS-21120-35

Device Problem Device Operates Differently Than Expected (2913)

Patient Problem Vascular Dissection (3160)

Event Date 05/25/2017

Event Type  Injury  

Manufacturer Narrative

Visual inspection of the returned device noted buckling of the distal portion of the catheter which is consistent with the report that the device was advanced against resistance into an area of vasospasm.The device instructions for use includes the following: "caution: do not advance or torque the system against resistance.If the cause of resistance cannot be determined, carefully withdraw catheter.".

Event Description

The physician was planning to use a surefire precision infusion system to perform a lower lobe kidney embolization through the renal artery.The physician tracked out to the desired location with a boston scientific renegade stc microcatheter and fathom 016 guide wire.The renegade microcatheter was removed and exchanged for the surefire precision infusion system which was tracked over the guidewire.When the surefire precision infusion system exited the guide catheter, arterial vasospasm was encountered.The physician attempted to advance the surefire precision infusion system through the area of vasospasm.This resulted in dissection of the vessel.Physician intervention was required to stop the bleeding and remove thrombosis from the artery.The patient was admitted to the hospital overnight for monitoring and released the following day.

• Brand Name: SUREFIRE PRECISION INFUSION SYSTEM
• Type of Device: INTRAVASCULAR DIAGNOSTIC CATHETER
• Manufacturer (Section D): SUREFIRE MEDICAL, INC.; 6272 w. 91st avenue; westminster CO 80031
• Manufacturer (Section G): SUREFIRE MEDICAL, INC.; 6272 w. 91st avenue; westminster CO 80031
• Manufacturer Contact: lynne aronson ; 6272 w. 91st avenue; westminster, CO 80031 ; 3034261222
• MDR Report Key: 6645256
• MDR Text Key: 77701184
• Report Number: 3010909876-2017-00001
• Device Sequence Number: 1
• Product Code: DQO
• UDI-Device Identifier: 00857136004088
• UDI-Public: 00857136004088
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K143588
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 06/14/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/15/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Physician
• Device Expiration Date: 10/31/2018
• Device Catalogue Number: SPS-21120-35
• Device Lot Number: 161118A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/26/2017
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 05/25/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/30/2016
• 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): Hospitalization; Required Intervention