MAUDE Adverse Event Report: STRYKER NEUROVASCULAR-UTAH-SALT LAKE CITY FLOWGATE2 8F X 85CM; CATHETER, PERCUTANEOUS

Catalog Number	90485
Medical Device Problem Codes	Fluid/Blood Leak (1250); Fracture (1260)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/27/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the balloon catheter (subject device) fractured within the patient and the balloon was noted to be leaking when it was within the patient.The subject device was replaced, and the procedure was completed successfully.No clinical consequences were reported to the patient due to this event.
Event or Problem Description
It was reported that the balloon catheter (subject device) fractured within the patient and the balloon was noted to be leaking when it was within the patient.The subject device was replaced, and the procedure was completed successfully.No clinical consequences were reported to the patient due to this event.
Additional Manufacturer Narrative
D4 ¿ expiration date ¿ added d4 ¿ gtin ¿ updated h4 ¿ manufacturing date - added there are controls in the manufacturing process to ensure the product met specifications upon release.During visual inspection, the balloon catheter was found to be kinked/bent.The balloon was detached/broken at the proximal end of the balloon.The balloon material had become inverted over the distal tip of the balloon catheter shaft.The balloon catheter shaft distal tip opening was deformed.During functional inspection an attempt was made to inflate the balloon.This was not possible due to the level of damage noted to the balloon during the visual inspection.The reported event is covered in the device directions for use (dfu).As well, the risk of the reported event is documented in the risk documentation and there are current controls to mitigate the risk of the as reported event.) the as reported (ar) events ¿balloon catheter broken/fractured during use¿ and ¿balloon leaked during use¿ could not be replicated during analysis.However, the analysis results are consistent with the reported event.The returned device did not meet specifications when received for complaint investigation based on the analyzed anomalies noted to the device.Additional information received indicated that the device was prepared for use as per the directions for use.There was no damage noted to the packaging prior to opening the packaging and the device was confirmed to be in good condition prior to use on the patient.It was reported that 'this product was opened as a guiding catheter for acute stroke treatment.The balloon was deflated outside the body using dry aspiration, filled with 50% diluted contrast medium, and test dilated, but the balloon was found to be cracked and its use was abandoned'.In the follow-up good faith effort responses, it was clarified that the leak was noted when the balloon was inside the patient.This was the time that the balloon catheter fracture was noted.The balloon catheter shaft was noted to be kinked/bent along its length.The balloon was noted to be broken/fractured at the proximal end of the balloon / balloon bond.The balloon material had become inverted and was covering the distal tip opening of the catheter shaft.The distal tip opening was noted to be deformed.It is not clear how the observed damage could have occurred to the balloon catheter.The as reported event ¿balloon catheter broken/fractured during use¿ and ¿balloon leaked during use¿ as well as the as analysed events ¿balloon catheter kinked/bent¿, ¿balloon failed to inflate¿, ¿balloon detached/separated¿, ¿balloon damaged¿, ¿balloon catheter tip damaged¿ will be assigned procedural factors as this complaint appears to be associated with a product that met stryker design and manufacturing specifications and appears to have been used in accordance with the dfu but performance was limited due to procedural and/or anatomical factors during use.

• Brand Name: FLOWGATE2 8F X 85CM
• Common Device Name: CATHETER, PERCUTANEOUS
• Manufacturer (Section D): STRYKER NEUROVASCULAR-UTAH-SALT LAKE CITY; 4870 west 2100 south; salt lake city UT 84120
• Manufacturer (Section G): STRYKER NEUROVASCULAR-UTAH-SALT LAKE CITY; 4870 west 2100 south; salt lake city UT 84120
• Manufacturer Contact: tara lopez ; 47900 bayside parkway; fremont, CA 94538 ; 5104132500
• MDR Report Key: 22337520
• Report Number: 3012931345-2025-00108
• Device Sequence Number: 15685987
• Product Code: DQY
• UDI-Device Identifier: 00815742004854
• UDI-Public: (01)00815742004854(17)250808(10)0000547149
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K153729
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 09/05/2025

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: 08/08/2025
• Device Catalogue Number: 90485
• Device Lot Number: 0000547149
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/10/2025
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 06/05/2025
• Supplement Date Received by Manufacturer: 08/18/2025
• Initial Report FDA Received Date: 06/26/2025
• Supplement Report FDA Received Date: 09/05/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/10/2023
• 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): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown