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

Catalog Number	90495
Medical Device Problem Code	Material Rupture (1546)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/25/2023
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during the procedure, the physician followed the standard procedure to introduce the subject balloon into the patient anatomy.The subject balloon ruptured when inflating pressure reached to 6 atm.Physician removed the whole system and found that the tip of the intermediate catheter was deformed.The physician replaced the subject balloon with a new device and continued the procedure without clinical consequences to the patient.
Additional Manufacturer Narrative
H3 other text : the device is not available to the manufacturer.
Event or Problem Description
It was reported that during the procedure, the physician followed the standard procedure to introduce the subject balloon into the patient anatomy.The subject balloon ruptured when inflating pressure reached to 6 atm.Physician removed the whole system and found that the tip of the intermediate catheter was deformed.The physician replaced the subject balloon with a new device and continued the procedure without clinical consequences to the patient.
Additional Manufacturer Narrative
There are controls in the manufacturing process to ensure the product met specifications upon release.During visual/microscopic inspection, the balloon catheter was found to be flattened/crushed.The peel away sheath was found to be present on the balloon catheter.There were no visual defects noted the balloon.During functional inspection, balloon burst/ruptured functional test was performed.The balloon could be inflated; however, the leakage was noted.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 balloon burst/ruptured could not be confirmed; however, the leakage was noticed during the analysis.The device failed to meet specification when received, due to the damage noted.Additional 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, continuous flush was set up and maintained and the patients anatomy was described as 'severely torturous'.The device was returned.There were no visual defects noted to the balloon.The balloon catheter was found to be flat/crushed.There was balloon leak noted during the functional test.It is probable that the severely tortuous anatomy may have caused friction, damages to the leakage during use.An assignable code of not confirmed will be assigned to the as reported "balloon burst/ruptured during use" as the defect was no confirmed during the analysis.An assignable cause of procedural factors will be assigned to the as analyzed "balloon leaked during use" and "balloon catheter flat/crushed", 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.

• 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: 17546814
• Report Number: 3012931345-2023-00190
• Device Sequence Number: 7420712
• Product Code: DQY
• UDI-Device Identifier: 00815742004953
• UDI-Public: 00815742004953
• Combination Product (Y/N): N
• Initial Reporter Country: TW
• 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): 11/01/2023

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: 05/19/2024
• Device Catalogue Number: 90495
• Device Lot Number: 0000135021
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 07/25/2023
• Supplement Date Received by Manufacturer: 10/10/2023
• Initial Report FDA Received Date: 08/14/2023
• Supplement Report FDA Received Date: 11/01/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/21/2022
• 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 7 ASPIRATION CATHETER (STRYKER)
• Patient Age: 76 YR
• Patient Sex: Male