MAUDE Adverse Event Report: VOLCANO CORPORATION PRIMEWIRE PRESTIGE PLUS; WIRE, GUIDE, CATHETER

Model Number	9185
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Death (1802)
Date of Event	01/05/2017
Type of Reportable Event	Death
Additional Manufacturer Narrative
(b)(4).
Event or Problem Description
This case was reviewed and investigated according to the manufacturer's policy.The customer reported that after ivus was completed and removed, we [the physician] inserted the [manufacturers device].Had difficulty at the left main, and then noticed no flow.Removed wire and began cpr, patient expired 30 minutes later on the procedure table.Patient condition: death.Vessel details: mid/distal lad, 4.2mm two (2) area plaque burden.It was further reported the patient had been diagnosed with cancer and was scheduled to be sent for treatment.Pre-cancer treatment labs revealed elevated levels of troponin.The patient was sent for an angiogram.During the angiogram the physician inserted and removed ivus catheter to successfully measure the plaque burden.When advancing the manufacturers device within the guide catheter to measure ffr, prior to normalization, the patient began to code.All devices were removed from the patient and cpr was initiated.Thirty (30) minutes later the patient expired on the table.No damage was observed during prep.No resistance was met and device was not stuck.The device was not returned to the manufacturer for evaluation.Other devices in use: boston scientific guide catheter lbu3.75, terumo run through wire, introducer needle (manufacturer not provided).The instructions for use (ifu) warns, adverse effects: as with all catheterization procedures, complications may be encountered with the use of the [manufacturers] guide wire.The major risks of coronary angiography and coronary angioplasty include: coronary vessel dissection, occlusion, perforation, embolus, spasm, local and/or systemic infection, pneumothorax, myocardial infarction, serious arrhythmias and death.The major risks of peripheral angiography or peripheral angioplasty include: dissection, abrupt closure, perforation, embolus, and spasm.Additionally, the instructions for use (ifu) warns, precautions: the functional measurement (pressure or flow) wire should not be advanced if resistance is encountered.The wire should never be forcibly pushed into a vessel.Anytime that resistance is encountered, the wire should be withdrawn under fluoroscopic guidance.This mdr is being submitted due to the death of the patient.The manufacturing documentation for this device was reviewed and the device met all quality and manufacturing release criteria.There were no nonconforming material reports or deviations noted that would contribute to the reported failure mode.This complaint will be monitored as part of complaint data analysis.
Additional Manufacturer Narrative
(b)(4).The customer reported that after ivus was completed the ivus catheter was removed.The ivus catheter device referenced was manufactured by this company.The physician did not believe either the manufacturer's ivus catheter or ffr wire contributed to the adverse event.A medwatch report was submitted on 02-03-2017 under mdr 2939520-2017-00014 for the ivus catheter.This follow-up report is to clarify the two mdrs are tied to the same procedure and note that an mdr was submitted for each device and note the mdr for this submission, 2939520-2017-00011, was also identified within mdr 2939520-2017-00014.

• Brand Name: PRIMEWIRE PRESTIGE PLUS
• Common Device Name: WIRE, GUIDE, CATHETER
• Manufacturer (Section D): VOLCANO CORPORATION; 3661 valley center dr, ste 200; san diego CA 92130
• MDR Report Key: 6294485
• Report Number: 2939520-2017-00011
• Device Sequence Number: 919453
• Product Code: DQX
• UDI-Device Identifier: 00845225001100
• UDI-Public: (01)00845225001100(17)191031
• Combination Product (Y/N): N
• Initial Reporter State: LA
• Initial Reporter Country: US
• PMA/510(K) Number: K111395
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 01/05/2017

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: Health Professional
• Device Expiration Date: 10/31/2019
• Device Model Number: 9185
• Device Catalogue Number: 400-0300.03
• Device Lot Number: 0110 50081322
• Was Device Available for Evaluation?: No
• Type of Report(Section G): FDA Requested
• Initial Date Received by Manufacturer: 01/05/2017
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 02/01/2017
• Supplement Report FDA Received Date: 02/22/2017
• 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: Death
• Patient Age: 63 YR
• Patient Weight: 100