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

Model Number 90485

Device Problem Material Puncture/Hole (1504)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 03/16/2021

Event Type  malfunction  

Manufacturer Narrative

Device is not available to manufacturer.

Event Description

It was reported that the balloon catheter (subject device) had a hole during the procedure.The procedure was completed successfully.No clinical consequences were reported to the patient due to this event.

Event Description

It was reported that the balloon catheter (subject device) had a hole during the procedure.The procedure was completed successfully.No clinical consequences were reported to the patient due to this event.

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.There are controls in the manufacturing process to ensure the product met specifications upon release.During visual inspection, the balloon catheter was found to be severely kinked/bent in a few places and the balloon was found to have a hole/perforation.Functional test was unable to perform due to damage to the device; however the defect was confirmed during the visual inspection.The reported events were confirmed during the device analysis.The device failed to meet specification when returned for analysis.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.It is probable that the device sustained damage during the clinical procedure causing the reported event.An assignable cause of procedural factors will be assigned to the reported and analyzed balloon has hole/perforation during use and to the analyzed balloon catheter kinked/bent, 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 85CM
• Type of Device: 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: 12144070
• MDR Text Key: 260766894
• Report Number: 3012931345-2021-00110
• Device Sequence Number: 1
• Product Code: DQY
• UDI-Device Identifier: 00815742004854
• UDI-Public: 00815742004854
• Combination Product (y/n): N
• Reporter Country Code: AS
• PMA/PMN Number: K153729
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional
• Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date: 12/14/2021

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
• Device Operator: Health Professional
• Device Expiration Date: 07/14/2022
• Device Model Number: 90485
• Device Catalogue Number: 90485
• Device Lot Number: 0000048546
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/16/2021
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 06/16/2021
• Initial Date FDA Received: 07/09/2021
• Supplement Dates Manufacturer Received: 11/30/2021
• Supplement Dates FDA Received: 12/14/2021
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/15/2020
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1