MAUDE Adverse Event Report: STRYKER SUSTAINABILITY SOLUTIONS PHOENIX; REPROCESSED INTRAVASCULAR ULTRASOUND CATHETER

Model Number	10135936
Medical Device Problem Code	Poor Quality Image (1408)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	01/14/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device was returned to stryker sustainability solutions for evaluation.Upon visual inspection of the received complaint device,transducer lens delamination was identified as a result of damage to the distal tip.Functional inspection revealed the device failed duc first call element testing, was identified to have significant delamination in first call element testing, did not meet specification for fractional bandwidth, did not meet specification for pulse width and had weak elements.A review of the dhr supports that the device met all inspection and test criteria prior to release from stryker.Therefore, the most likely root cause is lens delamination as a result of mishandling subsequent to distribution from stryker.The instructions for use (ifu) state: inspect the catheter for overall condition and physical integrity.Do not use the catheter if any damage is noted.If such problems exist, return the catheter and packaging to stryker sustainability solutions.For proper care and handling of the ultrasound catheter, always hold the ultrasound catheter by the handle and support the catheter shaft.Avoid touching the ultrasound catheter interconnect tab.Lift the lever on the connector, slipping it onto the catheter interconnect tab until fully mated with the steering handle.Push the lever down, locking into place.Ultrasound catheters are connected to standard ultrasound equipment using appropriate connectors.Storage and handling.Store reprocessed ultrasound catheters in a cool, dry place.Relative humidity: up to 90% non-condensing.Temperature: maximum 50°c (122°f), minimum -10°c (14°f).The reported event will continue to be monitored through post-market surveillance.
Event or Problem Description
It was reported that the diagnostic ultrasound catheter had poor image quality.The device was replaced and the procedure was completed successfully.There was no patient injury, medical intervention, or extended procedure time reported.These are commonly used devices that are readily available.

• Brand Name: NA
• Common Device Name: REPROCESSED INTRAVASCULAR ULTRASOUND CATHETER
• Manufacturer (Section D): STRYKER SUSTAINABILITY SOLUTIONS PHOENIX; 10232 s. 51st st.; phoenix AZ 85044
• MDR Report Key: 9803186
• Report Number: 0002090040-2020-00008
• Device Sequence Number: 19525690
• Product Code: OWQ
• UDI-Device Identifier: 00885825011376
• UDI-Public: 00885825011376
• Combination Product (Y/N): N
• Initial Reporter State: AZ
• Initial Reporter Country: US
• PMA/510(K) Number: K063076
• 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): 03/06/2020

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: 10/23/2021
• Device Model Number: 10135936
• Device Catalogue Number: 10135936RR
• Device Lot Number: 4046954
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/17/2020
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 02/11/2020
• Initial Report FDA Received Date: 03/06/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): Yes
• Patient Sequence Number: 1