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

Model Number	401932
Medical Device Problem Code	Entrapment of Device (1212)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	12/18/2019
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 at 2 cm and 14 cm from the distal tip of the device.The device did not meet the curve nor planarity specification.A review of the dhr supports that the device met all inspection and test criteria prior to release from stryker.The most likely root cause is mishandling subsequent to distribution, including shipping/storage conditions or improper manipulation of the catheter.The instructions for use (ifu) state: do not introduce the tip folded into the guiding sheath.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.The reported event will continue to be monitored through post-market surveillance.
Event or Problem Description
It was reported that the electrophysiology catheter steering mechanism failed and the doctor had difficulty removing the device from the patient's body.The catheter was stuck in the patient's heart and was not deflecting.Two additional physicians and two additional devices were required to remove the electrophysiology catheter.There was a delay in the case of approximately 45 minutes to remove and replace the device.The patient was fine and there was no patient injury.These are commonly used devices that are readily available.
Event or Problem Description
It was reported that the electrophysiology catheter steering mechanism failed and the doctor had difficulty removing the device from the patient's body.The catheter was stuck in the patient's heart and was not deflecting.Two additional physicians and two additional devices were required to remove the electrophysiology catheter.There was a delay in the case of approximately 45 minutes to remove and replace the device.The patient was fine and there was no patient injury.These are commonly used devices that are readily available.
Additional Manufacturer Narrative
On 11/18/2020, stryker sustainability solutions became aware that mdr section b2.(outcomes attributed to ae) was not completed for this mdr.This supplemental mdr serves to provide this information.The reported event will continue to be monitored through post market surveillance.

• 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: 9591071
• Report Number: 0002090040-2020-00001
• Device Sequence Number: 534845
• Product Code: NLH
• UDI-Device Identifier: 00885825007355
• UDI-Public: 00885825007355
• Combination Product (Y/N): N
• Initial Reporter State: CT
• 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,other
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 12/04/2020

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: 09/30/2021
• Device Model Number: 401932
• Device Catalogue Number: 401932RR
• Device Lot Number: 4025136
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/30/2019
• Initial Date Received by Manufacturer: 12/20/2019
• Supplement Date Received by Manufacturer: 11/18/2020
• Initial Report FDA Received Date: 01/15/2020
• Supplement Report FDA Received Date: 12/04/2020
• 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: Hospitalization; Required Intervention