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

Model Number	90485
Medical Device Problem Code	Material Rupture (1546)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/23/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device is not available to the manufacturer.
Event or Problem Description
It was reported that a neurovascular procedure was performed in a patient for ais (acute ischemic stroke).During preparation air was extracted out of the subject balloon, but no test of the subject balloon was performed prior to use in patient.During the procedure the subject balloon broke inside the patient.The subject balloon was replaced with another device and the procedure was completed successfully.No clinical consequences were reported to the patient due to this event.No further information is available.
Additional Manufacturer Narrative
H3 summary attached - updated.H3 device evaluated by mfg ¿updated.H4 manufacturing date ¿ added.D4 expiration date - added.D10 product available to stryker ¿ updated.D10 returned to manufacturer on ¿updated.There are controls in the manufacturing process to ensure the product met specifications upon release.Visual/microscopic inspection: the balloon catheter was found to be damaged.Functional inspection: balloon burst/ruptured functional test ¿ fail.The balloon could not be inflated due to rupture.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 complaint code was confirmed during device analysis.The analysis results are consistent with the reported event.The device did not met specifications when received for complaint investigation based on the functional and visual anomalies noted to the returned device.Additional information received indicated that the device was not initially prepared for use as per the directions for use.Although air was extracted during preparation, no further testing was completed outside the patient.Therefore, the balloon was not successfully inflated during preparation.It was reported that 'the balloon broke during the intervention'.It is further reported that the balloon was inside the patient when the inflation issue occurred.During inspection the balloon catheter was noted to be damaged.The balloon could not be successfully inflated due to a leak noted during the functional test, thereby confirming the as reported complaint.Based on the investigation, it is probable that the subject device sustained damage during use due to procedural factors, possibly while it was advanced through the selected vessel to the treatment site.The physical damage (wrinkled, ruptured balloon) on the device is aligned with the impact on functional performance (inflation issues).The as reported code as well as the as analyzed codes 'balloon burst/ruptured during use', 'balloon failed to inflate' and 'balloon catheter damaged' will be assigned procedural factors as this complaint appears to be associated with a product that met stryker design and manufacturing specifications and was used in accordance with the dfu, but performance was limited due to procedural and/or anatomical factors during use.
Event or Problem Description
It was reported that a neurovascular procedure was performed in a patient for ais (acute ischemic stroke).During preparation air was extracted out of the subject balloon, but no test of the subject balloon was performed prior to use in patient.During the procedure the the subject balloon broke inside the patient.The subject balloon was replaced with another device and the procedure was completed successfully.No clinical consequences were reported to the patient due to this event.No further information is available.

• 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: 13983078
• Report Number: 3012931345-2022-00070
• Device Sequence Number: 14841509
• Product Code: DQY
• UDI-Device Identifier: 00815742004854
• UDI-Public: 00815742004854
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• 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): 07/14/2022

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: 07/18/2023
• Device Model Number: 90485
• Device Catalogue Number: 90485
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 03/23/2022
• Supplement Date Received by Manufacturer: 06/20/2022
• Initial Report FDA Received Date: 04/01/2022
• Supplement Report FDA Received Date: 07/14/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/19/2021
• 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
• Patient Sex: Unknown