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

Model Number 90495

Device Problem Material Puncture/Hole (1504)

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

Event Date 04/01/2022

Event Type  malfunction  

Event Description

It was reported that when the physician inflated the balloon (subject device) inside the artery, the balloon (subject device) was already damaged.The procedure was completed successfully.No clinical consequences were reported to the patient due to this event.Analysis of the returned device found that the balloon (subject device) had a hole/perforation during use.No clinical consequences were reported to the patient due to this event.

Manufacturer Narrative

There are controls in the manufacturing process to ensure the product met specifications upon release.During visual inspection, the balloon catheter shaft was found to be kinked/bent in multiply areas, the balloon was found to be damaged and have a hole/perforation.A functional inspection for the reported event balloon damaged was not available as defect was confirmed during visual inspection.Also, a functional inspection for the reported event balloon failed to inflate functional test was unable to perform 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 was confirmed based on the damage noted to the returned device.The device failed to meet specification when returned for analysis.It was reported that when the physician inflated the balloon inside the artery, the balloon was already damaged, so he assumes that the balloon was destroyed while inserting it into the introducer sheath.Additional information states that the device was prepared for use as per the directions for use, the device was confirmed to be in good condition during preparation/prior to use on the patient, continuous flush was set up and maintained throughout the clinical procedure and the patient¿s anatomy was moderately tortuous.The device was returned, and the balloon catheter was noted to be kinked, the balloon was damaged, and the balloon had a hole/perforation.It is probable that the device was damaged during insertion/ navigation causing the reported event.An assignable cause of procedural factors will be assigned to the reported ¿balloon damaged¿ and ¿balloon failed to inflate¿ and to the analyzed ¿balloon catheter kinked/bent¿, ¿balloon 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.

• Brand Name: FLOWGATE2 8F X 95CM
• 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: 15099910
• MDR Text Key: 304601125
• Report Number: 3012931345-2022-00149
• Device Sequence Number: 1
• Product Code: DQY
• UDI-Device Identifier: 00815742004953
• UDI-Public: 00815742004953
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: K153729
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 07/25/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/25/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 09/20/2023
• Device Model Number: 90495
• Device Catalogue Number: 90495
• Device Lot Number: 0000079620
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/30/2022
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 07/18/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/21/2021
• 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
• Patient Age: 62 YR
• Patient Sex: Female