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

Model Number	401914
Medical Device Problem Code	Difficult to Remove (1528)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	06/16/2017
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The device has not yet been returned to stryker sustainability solutions for evaluation.Since there was no device returned, inspection has not yet been performed.A review of the dhr supports that the device met all inspection and test criteria prior to release from stryker.The reported event could be attributed to: - user error (including user technique and methods).- user expectation of the device's curve retention force.The instructions for use (ifu) state: - do not exert excessive pressure during placement of catheter if unknown resistance is encountered.- inspect the packaging and catheter for damage or defects prior to use.- do not attempt to use the reprocessed ep catheter prior to completely reading and understanding the directions for use.- avoid excessive torque, stretching, kinking and/or bending of catheter, as this may interfere with distal tip shaping or cause damage to internal electrode wires.- avoid manual pre-bending of distal curve, as this may damage steering mechanism of steerable catheters.Handle catheter with care to avoid improper electrical functioning.- do not insert or withdraw the catheter without straightening the catheter tip.A supplemental mdr will be submitted once the device evaluation is completed.The reported event will continue to be monitored through post market surveillance.(b)(4).
Event or Problem Description
It was reported that the catheter curve was unable to be manipulated with the steering cable.An additional catheter was required to assist with the removal of the device.There was no patient injury and extended procedure time reported was 15 minutes.These are commonly used devices that are readily available.
Additional Manufacturer Narrative
The complaint device was returned to stryker sustainability solutions after the initial mdr was filed.Visual inspection of the device revealed a bend approximately 4cm from the distal tip.Device inspection revealed the catheter did not meet curve and planarity specification.The reported event will continue to be monitored through post-market surveillance.
Event or Problem Description
It was reported that the catheter curve was unable to be manipulated with the steering cable.An additional catheter was required to assist with the removal of the device.There was no patient injury and extended procedure time reported was 15 minutes.These are commonly used devices that are readily available.

• 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: 6711927
• Report Number: 0002090040-2017-00004
• Device Sequence Number: 10818019
• Product Code: NLH
• UDI-Device Identifier: 00885825007294
• UDI-Public: (01)00885825007294(17)190418(10)3190305
• Combination Product (Y/N): N
• Initial Reporter State: ME
• Initial Reporter Country: US
• PMA/510(K) Number: K052603
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 08/24/2017

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
• Operator of Device: Health Professional
• Device Expiration Date: 04/18/2019
• Device Model Number: 401914
• Device Catalogue Number: 401914RR
• Device Lot Number: 3190305SH
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/21/2017
• Initial Date Received by Manufacturer: 06/16/2017
• Supplement Date Received by Manufacturer: 07/31/2017
• Initial Report FDA Received Date: 07/13/2017
• Supplement Report FDA Received Date: 08/24/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): Yes
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention