MAUDE Adverse Event Report: STRYKER NEUROVASCULAR-UTAH-SALT LAKE CITY FLOWGATE2 8F X 95CM; CATHETER, PERCUTANEOUS

Model Number	90495
Medical Device Problem Code	Fluid/Blood Leak (1250)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/21/2022
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during the internal carotid artery (ica) occlusion case, physician prepared to dilate the balloon of the subject balloon guide catheter using the 1 ml syringe.It was inflated at a nominal pressure but the balloon of the subject balloon guide catheter leaked.The physician replaced it with a new device and continued the procedure without clinical consequences to the patient.
Additional Manufacturer Narrative
C2/d10 concomitant products grid - updated h3 device evaluated by mfg ¿updated h3 summary attached - updated due to the automated manufacturing execution system (mes) there are controls in the manufacturing process to ensure the product met specifications upon release.During the visual inspection, the balloon catheter shaft was found to be severely kinked/bent in multiply areas.The tip of the balloon catheter shaft was found to be damaged.The balloon was found to have a hole/perforation.Functional testing was not performed due to condition of the device.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 reported event could not be confirmed; however, the analysis results are consistent with the reported event.The device did not meet specifications when received for complaint investigation based on the visual inspection.It was reported that the physician prepared to dilate the balloon guide catheter.Using 1:1 saline and contrast to dilate but the operator found the balloon leaked.As per the additional information, a 1ml syringe was used to inflate the balloon, the correct inflation medium used to inflate the balloon as per the dfu, the device was not inflated over nominal pressure or excessive pressure used, the balloon was able to be successfully inflated during preparation and the the patients anatomy was moderately tortuous.The device was returned for analysis and it was noted that the balloon catheter tip was damaged, catheter shaft was severely kinked and there was a hole noted to the balloon.It is probable that the device was damaged during use, causing the reported event.An assignable cause of procedural factors will be assigned to the reported 'balloon leaked during use' and to the analyzed 'balloon catheter kinked/bent', 'balloon catheter tip damaged' and 'balloon has hole/perforation during use', as the issue is associated with a product that meets stryker design and manufacture specifications and was used in according with the dfu but due to procedural and/or anatomical factors during use, the product performance was limited.
Event or Problem Description
It was reported that during the internal carotid artery (ica) occlusion case, physician prepared to dilate the balloon of the subject balloon guide catheter using the 1 ml syringe.It was inflated at a nominal pressure but the balloon of the subject balloon guide catheter leaked.The physician replaced it with a new device and continued the procedure without clinical consequences to the patient.

• Brand Name: FLOWGATE2 8F X 95CM
• 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: 15008539
• Report Number: 3012931345-2022-00143
• Device Sequence Number: 14032575
• Product Code: DQY
• UDI-Device Identifier: 00815742004953
• UDI-Public: 00815742004953
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• 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): 10/18/2022

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: 08/03/2023
• Device Model Number: 90495
• Device Catalogue Number: 90495
• Device Lot Number: 0000070122
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/04/2022
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 06/21/2022
• Supplement Date Received by Manufacturer: 09/22/2022
• Initial Report FDA Received Date: 07/13/2022
• Supplement Report FDA Received Date: 10/18/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/04/2021
• 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: AXS CATALYST 6 CATHETER (STRYKER); AXS CATALYST INTERMEDIATE CATHETER (STRYKER); SYNCHRO GUIDEWIRE (STRYKER); SYNCHRO GUIDEWIRE (STRYKER); TREVO PRO 18 MICROCATHETER (STRYKER); TREVO PRO18 MICROCATHETER(STRYKER)
• Patient Age: 64 YR
• Patient Sex: Male
• Patient Race: Asian