MAUDE Adverse Event Report: STRYKER-ENDOSCOPY PHOENIX USA; REPROCESSED INTRAVASCULAR ULTRASOUND CATHETER

Model Number	D087031
Medical Device Problem Code	Use of Device Problem (1670)
Health Effect - Clinical Code	Retroperitoneal Hemorrhage (4483)
Date of Event	12/02/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that after a pfa atrial fibrillation ablation a patient had a retroperitoneal "bleed".During the procedure the physician felt the ice catheter was advancing incorrectly.There was tortuous vasculature.The physician performed a contrast image of the ivc prior to transeptal and it revealed no issues.The patient pressures were stable throughout the procedure.The physician performed a repeat contrast image of the ivc post procedure, and it revealed no bleed.After the procedure the patients¿ blood pressure dropped and a ct revealed an rp bleed.The patient recovered.The suspected catheter was the view flex ice catheter.Multiple attempts were made to obtain additional information.No information was provided regarding patient injury, medical intervention, or extended procedure time reported.These are commonly used devices that are readily available.
Additional Manufacturer Narrative
The device was not returned to stryker sustainability solutions for evaluation.As the device was not returned for evaluation, inspection was unable to be performed.A review of the device history record (dhr) could not be performed as the device's lot and serial numbers were not reported.Stryker procedure(s) supports that the device was unlikely to have been released from stryker with the reported failure mode.Therefore, the likely root cause is mishandling subsequent to distribution, including shipping and storage conditions or improper manipulation of the device.The instructions for use (ifu) state: do not attempt to use the reprocessed viewflex xtra ice catheter prior to completely reading and understanding the directions for use.The reprocessed viewflex xtra ice catheters are supplied sterile only if packaging is not damaged or open.Inspect the packaging and catheter for damage or defects prior to use.The reprocessed viewflex xtra ice catheters have been sterilized using eto.Do not attempt to sterilize the catheters by autoclave, gamma or ultraviolet radiation, or liquid sterilizing solutions.Do not bend, kink, stretch, or forcefully wipe the catheter.These actions may damage the catheter.Do not use mechanical tools or forceps to grip the catheter.Storage and handling: room temperature: 18 degrees c to +26 degrees c (64 degrees f to 79 degrees f) use product on a first-in, first-out basis prior to expiration or use by date on the label transport: temperature: -20 degrees c to +50 degrees c (-4 degrees f to 122 degrees f).Relative humidity: 25% to 90%.The reported event will continue to be monitored through post-market surveillance.Should the device become available for return, the investigation will be reopened.

• Brand Name: NA
• Common Device Name: REPROCESSED INTRAVASCULAR ULTRASOUND CATHETER
• Manufacturer (Section D): STRYKER-ENDOSCOPY PHOENIX USA; 10232 s. 51st st.; phoenix AZ 85044
• Manufacturer (Section G): STRYKER-ENDOSCOPY PHOENIX USA; 10232 s. 51st st.; phoenix AZ 85044
• Manufacturer Contact: arsalan rizvi ; 1810 w. drake drive; tempe, AZ 85283 ; 8888883433
• MDR Report Key: 24004590
• Report Number: 0002090040-2026-00001
• Device Sequence Number: 10503244
• Product Code: OWQ
• UDI-Device Identifier: 07613327376067
• UDI-Public: 07613327376067
• Combination Product (Y/N): N
• Initial Reporter State: VA
• Initial Reporter Country: US
• PMA/510(K) Number: K231621
• 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): 01/08/2026

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: D087031
• Device Catalogue Number: D087031
• Device Lot Number: UNKOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 12/11/2025
• Initial Report FDA Received Date: 01/08/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown