MAUDE Adverse Event Report: STRYKER SUSTAINABILITY SOLUTIONS PHOENIX; CATHETER, RECORDING, ELECTRODE, REPROCESSED

Model Number	201102
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	08/08/2016
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The complaint device was returned to stryker sustainability solutions for an evaluation.A review of the device history record indicates the device met all inspection and test criteria prior to release.The device was visually inspected and a kink was found distal to the transition point.The device was functionally inspected and found to have electrical isolation failure.Therefore, the most likely root cause is electrical isolation failure as a result of mishandling, including shipping and storage conditions, subsequent to distribution from stryker.Inspect the catheter for overall condition and physical integrity.Do not use the catheter if electrodes appear loose or if any damage is noted.If such problems exist, return the catheter and packaging to stryker sustainability solutions.Electrical performance could be affected if the proximal handle, pig tail or cable connector are immersed in fluids.Confirm that the thumbknob is pulled back completely before insertion and that the loop-contraction mechanism is not activated, ensuring minimal tension to the nitinol loop.Adjust the loop diameter with the handle grip.Contract the loop by rotating the handle to the right, relax/expand the loop by rotating the handle to the left.Adjust the radius of curvature as necessary by manipulating the thumbknob.Curve the catheter tip by pushing the thumbknob forward; straighten the catheter tip by pulling the thumbknob back.The reported event will continue to be monitored through post-market surveillance.
Event or Problem Description
It was reported that there was noise on the device.There was no patient injury, medical intervention, or extended procedure time reported.

• Brand Name: NA
• Common Device Name: CATHETER, RECORDING, ELECTRODE, REPROCESSED
• Manufacturer (Section D): STRYKER SUSTAINABILITY SOLUTIONS PHOENIX; 10232 s. 51st st.; phoenix AZ 85044
• MDR Report Key: 5981098
• Report Number: 0002090040-2016-00011
• Device Sequence Number: 888647
• Product Code: NLH
• UDI-Device Identifier: 00885825003869
• UDI-Public: 00885825003869
• Combination Product (Y/N): N
• PMA/510(K) Number: K030187
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Biomedical Engineer
• Type of Report: Initial
• Report Date (Section B): 08/15/2016

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: Health Professional
• Device Model Number: 201102
• Device Catalogue Number: 201102CO
• Device Lot Number: 2923186SH
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/31/2016
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/14/2016
• Initial Report FDA Received Date: 09/27/2016
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): Yes
• Patient Sequence Number: 1