MAUDE Adverse Event Report: VOLCANO ATHEROMED, INC. 2.2MM X 149CM PHOENIX ATHERECTOMY CATHETER; CATHETER, PERIPHERAL, ATHERECTOMY

Model Number P22149K

Device Problem Retraction Problem (1536)

Patient Problems Death (1802); Pneumonia (2011); Sepsis (2067); Vasoconstriction (2126); Device Embedded In Tissue or Plaque (3165)

Event Date 03/15/2017

Event Type  Death  

Manufacturer Narrative

(b)(4).This case was reviewed and investigated according to the manufacturer's policy.Manufacturer was informed the patient expired.Investigation is in progress to obtain additional information.The implant or explant dates are not applicable to this device.The device was returned for analysis on 03-27-2017.The analysis is in progress.

Event Description

It was reported by the physician during a peripheral therapeutic procedure the device became lodged in infra-popliteal space due to suspected acute vessel spasm by the physician.Despite administration of nitroglycerin to relax vessel and removing the drive unit to release the device, the operator was unable to extract the device.Upon further application of force, the device stretched and separated approximately 10cm proximal to the distal tip.This 10cm section remained inside the body.The residual piece was unable to be removed after nitrogylcerin administration and attempting to remove intravascularly with a 4fr en-snare.The patient procedure was converted to an open surgical procedure and the device was removed surgically with a distal sfa to distal popliteal bypass graft.By report, the patient expired post-procedure.

Manufacturer Narrative

(b)(4).This case has been investigated in accordance with the manufacturers policy.This supplemental report is being submitted because the device has been analyzed, additional information has been received and for correction of previously reported data.Correction: there is no serial number for this device.Lot number reported was for the kit and not the catheter.The facility reported the event under maude adverse event report (b)(4).Updated to reflect the device has been evaluated by the manufacturer.The device was returned and evaluated in accordance with manufacturers policy.Visual inspection was completed prior to the decontamination process and subsequently returned to the hospital for pathology.Minimal handling of the product was completed as there was no decontamination process performed.Only non-destructive analysis was performed.During visual inspection it was confirmed there was a separation of the catheter.The site of separation was approximately 2 inches from the distal end (cutter end).Stretching and twisting of the shaft was evident at the sites distal and proximal to separation location, indicative of a pull or tensile and torsional stress overload condition resulting in the catheter break.The catheter torque shaft was also subjected to a tensile load which caused it to fail in a similar fashion.Additionally, the condition of the remaining vessel material about the catheter appeared twisted, and tightly encased the catheter shaft.Per the instructions for use (ifu) per table 1, catheter key specifications, on page 2 indicates for the model / length of this catheter, that the minimum vessel diameter be 3.0 mm.Warnings on page 2 indicate: · do not operate the atherectomy system in vessels smaller than the indicated size as perforation, dissection or injury may occur.· when the atherectomy catheter is exposed to the vascular system, it should not be advanced or retracted except under direct fluoroscopic observation.If resistance is met during advancement or retraction, determine the cause of the resistance before continuing.In this case, resistance was encountered, and pulling against resistance may result in catheter fracture or patient injury.The twisted state of the tissue suggests that the entire unit was rotated during the attempted extraction which may have resulted in the vessel dissection or damage.An independent third party failure analysis company evaluated the fractured surfaces.Scanning electron microscope (sem) analysis concluded that there were no defects found in the analyzed fractured surfaces and that the catheter had ruptured due to tensile overload.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.To date, no other complaints were reported for this same failure mode within this lot.Evaluation codes: updated per investigation findings.Per facility report, the patient developed pneumonia and became septic.

Manufacturer Narrative

Internal reference: (b)(4).This case was reviewed and investigated according to the manufacturer's policy.The patients date of death is reported as (b)(6) 2017.

Event Description

This supplemental follow-up report is being submitted because additional information was obtained.

• Brand Name: 2.2MM X 149CM PHOENIX ATHERECTOMY CATHETER
• Type of Device: CATHETER, PERIPHERAL, ATHERECTOMY
• Manufacturer (Section D): VOLCANO ATHEROMED, INC.; 1455 adams drive, suite 1120; menlo park CA 94025
• Manufacturer (Section G): VOLCANO ATHEROMED, INC.; 1455 adams drive, suite 1120; menlo park CA 94025
• Manufacturer Contact: tom brennan ; 3721 valley centre dr #500; san diego, CA 92130 ; 8587641320
• MDR Report Key: 6494561
• MDR Text Key: 72876237
• Report Number: 2939520-2017-00040
• Device Sequence Number: 1
• Product Code: MCW
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K143328
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date: 03/16/2017

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?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 10/31/2018
• Device Model Number: P22149K
• Device Lot Number: 09271608
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/27/2017
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 03/16/2017
• Initial Date FDA Received: 04/14/2017
• Supplement Dates Manufacturer Received: 06/02/2017; 07/07/2017
• Supplement Dates FDA Received: 06/30/2017; 08/04/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/08/2016
• 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): Death
• Patient Age: 86 YR
• Patient Weight: 70