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

Model Number	D7-T20-282-RT
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	09/21/2016
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The device was returned to stryker sustainability solutions for evaluation.Upon visual inspection of the received complaint device, bends were identified approximately 16cm, 9.5cm, and 4.5cm from the distal tip, which are distal to the transition point.A review of the device history record indicates the device met all inspection and test criteria prior to release.Therefore, the most likely root causes are kinks leading to an improper curve as a result of mishandling subsequent to distribution from stryker.The instructions for use state: do not exert excessive pressure during placement of catheter if unknown resistance is encountered.Do not attempt to use the reprocessed ep catheter prior to completely reading and understanding the directions for use.Avoid manual pre-bending of distal curve, as this may damage steering mechanism of steerable catheters.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.The reported event will continue to be monitored through post market surveillance.
Event or Problem Description
It was reported that the device became knotted while in the patient and was untangled by physician without incident.Two additional duo catheters were used to untie the device.There was no patient injury and extended procedure time reported was minimal.
Additional Manufacturer Narrative
The device was returned to stryker sustainability solutions for evaluation.Upon visual inspection of the received complaint device, bends were identified approximately 16cm, 9.5cm, and 4.5cm from the distal tip, which are distal to the transition point.It is likely that the observed bends were a result of the device being knotted.A review of the device history record indicates the device met all inspection and test criteria prior to release.Therefore, the most likely root causes are kinks leading to an improper curve as a result of mishandling subsequent to distribution from stryker.The instructions for use state: - do not exert excessive pressure during placement of catheter if unknown resistance is encountered.- do not attempt to use the reprocessed ep catheter prior to completely reading and understanding the directions for use.- avoid manual pre-bending of distal curve, as this may damage steering mechanism of steerable catheters.-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.The reported event will continue to be monitored through post market surveillance.
Event or Problem Description
It was reported that the device became knotted while in the patient and was untangled by physician without incident.Two additional duo catheters were used to untie the device.There was no patient injury and extended procedure time reported was minimal.

• Brand Name: NA
• Common Device Name: CATHETER, RECORDING, ELECTRODE, REPROCESSED
• Manufacturer (Section D): STRYKER SUSTAINABILITY SOLUTIONS; 1810 w. drake drive; tempe AZ 85283
• MDR Report Key: 6042582
• Report Number: 0002090040-2016-00015
• Device Sequence Number: 13678633
• Product Code: NLH
• UDI-Device Identifier: 00885825001445
• UDI-Public: 00885825001445
• Combination Product (Y/N): N
• Initial Reporter State: CT
• Initial Reporter Country: US
• PMA/510(K) Number: K040751
• 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): 09/21/2016

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 Model Number: D7-T20-282-RT
• Device Catalogue Number: D7-T20-282-RTRR
• Device Lot Number: 2696022SH
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/29/2016
• Type of Report(Section G): FDA Requested
• Initial Date Received by Manufacturer: 09/21/2016
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 10/19/2016
• Supplement Report FDA Received Date: 10/31/2016
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): Yes
• Patient Sequence Number: 1
• Patient Age: 76 YR