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

Model Number	D6-DR-005-RT
Medical Device Problem Codes	Entrapment of Device (1212); Material Deformation (2976)
Health Effect - Clinical Code	Atrial Fibrillation (1729)
Date of Event	03/16/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The device was not returned to stryker sustainability solutions for evaluation.The facility stated the device will not be released.As the device was not returned for evaluation, inspection was unable to be performed.No device information was reported and the customer did not report lot# or serial # information.Therefore, the device history record (dhr) was unable to be verified.The reported event could be attributed to: user error (including user technique and methods) user moves the catheter incorrectly catheter curve shape inaccurate due to handling by the user 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.Should the device become available for return, the investigation will be re-opened.
Event or Problem Description
It was reported there was a complication during an ablation procedure conducted (b)(6) 2021, with a retained knotted left femoral vein catheter.The catheter wires entangled and had to be surgically removed.The reported issue occurred 10 minutes into the procedure.There was extended procedure time reported.However, the length of the extended procedure time was not reported.The procedure was not completed successfully as the ablation procedure was aborted and had to be rescheduled.It was reported the patient had no residual issue post removal.Following the aborted procedure, it was reported the patient had an episode of a-fib since leaving the hospital.The patient had the rescheduled ablation procedure done (b)(6) 2021.The rescheduled procedure was completed successfully.

• 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: 11729173
• Report Number: 0002090040-2021-00013
• Device Sequence Number: 3550601
• Product Code: NLH
• UDI-Device Identifier: 00885825000875
• UDI-Public: 00885825000875
• Combination Product (Y/N): N
• Initial Reporter State: PA
• Initial Reporter Country: US
• PMA/510(K) Number: K012708
• 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
• Report Date (Section B): 04/26/2021

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: No Information
• Device Model Number: D6-DR-005-RT
• Device Catalogue Number: D6-DR-005-RTRR
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 03/29/2021
• Initial Report FDA Received Date: 04/26/2021
• 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
• Patient Age: 61 YR
• Patient Weight: 100