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

Catalog Number	90485
Medical Device Problem Code	Material Rupture (1546)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/29/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during right m1 occlusion mechanical thrombectomy procedure, subject balloon of the balloon catheter was ruptured when approx.0.5cc of 50/50 contrast saline was injected into the balloon.The procedure was completed successfully.No clinical consequences were reported to the patient due to this event.
Additional Manufacturer Narrative
There are controls in the manufacturing process to ensure the product met specifications upon release.The subject balloon catheter was not returned for analysis; therefore, physical as well as a functional testing could not be performed.The reported event is covered in the device direction 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 reported complaint could not be confirmed, and it could not be definitively determined if the device failed to meet specifications, because the product was not returned.Addition information received indicated that the device was prepared for use as per the directions for use.The device was confirmed to be in good condition prior to use on the patient and the balloon was successfully inflated/deflated during preparation with no leakage noted.It was reported that 'the bgc was prepared according to the instruction for use (ifu) before being advanced into the patient.It was initially positioned at the petrous segment of internal carotid artery (ica), however, due to vasospasm, the physician repositioned the subject device to cervical ica.The balloon was inflated using 50/50 contrast-saline prior to retrieving of the clot.However, it ruptured when approx.0.5cc of 50/50 contrast saline was injected'.While there are a number of potential causes for the reported issue, because review and analysis of available information failed to identify a definitive cause and the device was not returned, an assignable cause of undeterminable will be assigned to this complaint.
Event or Problem Description
It was reported that during right m1 occlusion mechanical thrombectomy procedure, subject balloon of the balloon catheter was ruptured when approx.0.5cc of 50/50 contrast saline was injected into the balloon.The procedure was completed successfully.No clinical consequences were reported to the patient due to this event.

• 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 CORK; ida industrial estate; model farm road; cork UT NA ; EI NA
• Manufacturer Contact: tara lopez ; 47900 bayside parkway; fremont, CA 94538 ; 5104132500
• MDR Report Key: 20817170
• Report Number: 3012931345-2024-00206
• Device Sequence Number: 7803990
• Product Code: DQY
• UDI-Device Identifier: 00815742004854
• UDI-Public: (01)00815742004854(17)251003(10)0000566778
• Combination Product (Y/N): N
• Initial Reporter Country: MY
• 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): 02/07/2025

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: 10/03/2025
• Device Catalogue Number: 90485
• Device Lot Number: 0000566778
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 11/06/2024
• Supplement Date Received by Manufacturer: 01/17/2025
• Initial Report FDA Received Date: 12/02/2024
• Supplement Report FDA Received Date: 02/07/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 10/05/2023
• 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
• Concomitant Medical Products and Therapy/Usage Dates: PHENOM 21 MICROCATHETER (MEDTRONIC).; SHORT SHEATH (TERUMO).; SOFIA CATHETER (TERUMO).
• Patient Age: 58 YR
• Patient Sex: Male