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

Model Number	90495
Medical Device Problem Code	Leak/Splash (1354)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/11/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device is not available to the manufacturer.
Event or Problem Description
It was reported after insertion into the aorta (subject balloon was not yet inflated) spontaneous blood reflux in the balloon inflation channel.The procedure was completed successfully.No clinical consequences were reported to the patient due to this event.
Event or Problem Description
It was reported after insertion into the aorta (subject balloon was not yet inflated) spontaneous blood reflux in the balloon inflation channel.The procedure was completed successfully.No clinical consequences were reported to the patient due to this event.
Additional Manufacturer Narrative
H4 manufacturing date ¿ added.H3 device evaluated by mfg ¿updated.H3 summary attached - updated.D4 expiration date - added.D9 product available to stryker updated.D9 returned to manufacturer on updated.Based on the results of the dhr (device history record) review, there is no indication that the device, labeling or packaging failed to meet its specifications when released.During visual inspection, dried blood was noted within the balloon catheter, both in the side arm (inflation port of the balloon) and in the main (guidewire) shaft lumen.During a functional test, an attempt was made to inflate the balloon using water and a 35cm long cut/tear was noted approximately 57cm from the proximal end of the balloon catheter which immediately leaked.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 'balloon leaked during use' could not be confirmed; however, the analysis results are consistent with the reported event.The device failed to meet specifications when received for complaint investigation based on the analyzed anomalies noted to the device.There was very little additional information provided by the customer.It was reported that 'after insertion into the aorta (balloon was not yet inflated) spontaneous blood reflux in the balloon inflation channel.The client suspects a pre-existing leakage of the balloon'.The balloon catheter was returned for analysis and dried blood was noted in the inflation port and also in the main catheter shaft lumen.An attempt was made to inflate the balloon but this was unsuccessful due to a 35cm tear along the outer layer of the catheter approx.57cm from the proximal end of the balloon catheter.It is unclear when this damage to the balloon catheter outer shaft occurred as it is unclear from the answers received as part of the gfe process if the balloon was inflated and then delated prior to use on the patient (as directed in the dfu).There are inspections and functional tests performed on each balloon device prior to it being shipped from the manufacturing site so the device would not have been shipped out with this damage.Assuming that the device was prepared per the dfu instructions prior to use (inflate the balloon to check for leaks) with no inflation failure, the cut could have occurred while inserting the balloon catheter through the introducer sheath or handling prior to use.Therefore, the as reported 'balloon leaked during use' as well as the as analyzed 'balloon failed to inflate', 'balloon catheter shaft leaked during use', and 'balloon catheter damaged' will be assigned handling damage as this complaint is associated with a product that met stryker design and manufacturing specifications but the damage appears to be associated with handling of the product or portion of the product during preparation of the product prior to use.

• 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: 16970405
• Report Number: 3012931345-2023-00092
• Device Sequence Number: 20181515
• Product Code: DQY
• UDI-Device Identifier: 00815742004953
• UDI-Public: 00815742004953
• 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): 07/21/2023

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: 09/05/2024
• Device Model Number: 90495
• Device Catalogue Number: 90495
• Device Lot Number: 0000179648
• 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: 05/17/2023
• Supplement Date Received by Manufacturer: 07/13/2023
• Initial Report FDA Received Date: 05/19/2023
• Supplement Report FDA Received Date: 07/21/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/07/2022
• 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
• Patient Sex: Unknown