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

Catalog Number	SPS-21150-35
Medical Device Problem Codes	Break (1069); Device-Device Incompatibility (2919)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	06/06/2016
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Device disposed of by the customer.
Event or Problem Description
The physician was preparing to perform a liver embolization procedure.The celiac artery was accessed using a 5f angiographic catheter.The surefire precision infusion system was inserted into the angiographic catheter, but resistance was felt and the device stopped advancing.The physician attempted to retract the surefire precision from the angiographic catheter, but the device did not move.In accordance with the ifu, the physician was advised by a surefire representative to stop retracting against resistance and remove the surefire precision and the angiographic catheter from the patient as a single unit.Against advice, the physician continued to pull on the surefire precision, which resulted in breakage of the catheter shaft approximately 130cm from the proximal end.The tip of the surefire precision remained lodged in the angiographic catheter.The angiographic catheter with the surefire precision tip lodged inside were removed from the patient.The physician completed the procedure with another angiographic catheter and microcatheter.There was no patient injury.

• Brand Name: SUREFIRE PRECISION INFUSION SYSTEM
• Common Device Name: DIAGNOSTIC INTRAVASCULAR CATHETER
• Manufacturer (Section D): SUREFIRE MEDICAL, INC.; 6272 w. 91st avenue; westminster CO 80031
• MDR Report Key: 5759259
• Report Number: 3010909876-2016-00001
• Device Sequence Number: 625775
• Product Code: DQO
• UDI-Device Identifier: 00857136004095
• UDI-Public: 0857136004095
• Combination Product (Y/N): N
• Initial Reporter State: MA
• 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): 06/24/2016

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
• Operator of Device: Physician
• Device Expiration Date: 02/28/2018
• Device Catalogue Number: SPS-21150-35
• Device Lot Number: 160303A
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/08/2016
• Initial Report FDA Received Date: 06/29/2016
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1