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

Model Number	81945
Medical Device Problem Code	Mechanical Problem (1384)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/17/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device was returned to stryker sustainability solutions for evaluation.Upon inspection of the received complaint device, a bend was identified 10 cm from the distal tip, which is distal to the transition point.The handle, steering knob, connector, and electrodes appeared to be intact.The device was evaluated for deflection.The device did not meet curve specifications.The device did not meet the planarity specification.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 mishandling subsequent to distribution, including shipping/storage conditions or improper manipulation of the catheter.The instructions for use (ifu) 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.The reported event will continue to be monitored through post-market surveillance.
Event or Problem Description
It was reported catheter was not holding shape.There was no patient injury or medical intervention and extended procedure time reported was 20 minutes.These are commonly used devices that are readily available.
Event or Problem Description
It was reported catheter was not holding shape.There was no patient injury or medical intervention and extended procedure time reported was 20 minutes.These are commonly used devices that are readily available.
Additional Manufacturer Narrative
A review of mdrs filed from august 24, 2017, to july 19th, 2022, was conducted.Since august 24th, 2017, there has been one additional report (restarting the two-year reporting cycle on 01/15/2020) of serious injury or surgical intervention to preclude serious injury or permanent impairment related to this specific failure mode.Based on the analysis of mdr data compared to the firm¿s sales figures, the likelihood of this specific failure mode causing or contributing to another serious injury should the malfunction occur is considered negligible.As such, we will no longer be reporting for the failure mode of a deflectable ep catheter device having a bend along with curve shape and planarity that do not meet specification.

• Brand Name: NA
• Common Device Name: CATHETER, RECORDING, ELECTRODE, REPROCESSED
• Manufacturer (Section D): STRYKER SUSTAINABILITY SOLUTIONS PHOENIX; 10232 s. 51st st.; phoenix AZ 85044
• Manufacturer (Section G): STRYKER SUSTAINABILITY SOLUTIONS PHOENIX; 10232 s. 51st st.; phoenix AZ 85044
• Manufacturer Contact: andy dobos ; 1810 w. drake drive; tempe, AZ 85283 ; 8888883433
• MDR Report Key: 13122005
• Report Number: 0002090040-2021-00048
• Device Sequence Number: 4857075
• Product Code: NLH
• UDI-Device Identifier: 00885825010829
• UDI-Public: 00885825010829
• Combination Product (Y/N): N
• Initial Reporter State: ID
• Initial Reporter Country: US
• PMA/510(K) Number: K112232
• 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): 07/20/2022

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 Expiration Date: 06/09/2023
• Device Model Number: 81945
• Device Catalogue Number: 81945RR
• Device Lot Number: 4517815
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/29/2021
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 12/21/2021
• Supplement Date Received by Manufacturer: 06/22/2022
• Initial Report FDA Received Date: 12/30/2021
• Supplement Report FDA Received Date: 07/20/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/09/2021
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): Yes
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Patient Sex: Unknown