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

Catalog Number	SPS-21120-35
Health Effect - Clinical Code	Vascular Dissection (3160)
Date of Event	05/25/2017
Type of Reportable Event	Serious Injury
Additional 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 or Problem 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
• Common Device Name: INTRAVASCULAR DIAGNOSTIC CATHETER
• Manufacturer (Section D): SUREFIRE MEDICAL, INC.; 6272 w. 91st avenue; westminster CO 80031
• MDR Report Key: 6645256
• Report Number: 3010909876-2017-00001
• Device Sequence Number: 13676068
• Product Code: DQO
• UDI-Device Identifier: 00857136004088
• UDI-Public: 00857136004088
• Combination Product (Y/N): N
• Initial Reporter State: MD
• Initial Reporter Country: US
• PMA/510(K) Number: K143588
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 06/14/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: 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
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/25/2017
• Initial Report FDA Received Date: 06/15/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention