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

Catalog Number 90495

Device Problem Fluid/Blood Leak (1250)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 12/15/2019

Event Type  malfunction  

Manufacturer Narrative

Stryker device is not available.

Event Description

It was reported that the subject balloon did not inflate on the first attempt of injecting prescribed amount of contrast medium during the preparation.On the second attempt, the balloon inflated and was used for the procedure.The subject balloon was then found deflated inside the patient anatomy.The procedure was completed successfully and no clinical consequences were reported to the patient due to this event.

Manufacturer Narrative

The device was returned without packaging therefore; it cannot be confirmed that the correct device was returned.During visual inspection, the proximal end of the balloon catheter was bent.The balloon catheter was kinked at 57cm & 100cm from the proximal end.The distal 7cm of the balloon catheter was extensively flattened.During functional inspection, an attempt was made to inflate the balloon and it was noted to be leaking.Based on the results of the dhr review, there is no indication that the device, labeling or packaging failed to meet its specifications when released.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.During analysis, the device was visually inspected, and the catheter shaft was found to be kinked and severely flattened to the distal end.The balloon was noted to be leaking in an attempt to inflate.It is probable that the device was damaged during the clinical procedure causing the reported event.An assignable cause of procedural factors will be assigned to the reported events, as the issue is associated with a product that meets 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.

Event Description

It was reported that the subject balloon did not inflate on the first attempt of injecting prescribed amount of contrast medium during the preparation.On the second attempt, the balloon inflated and was used for the procedure.The subject balloon was then found deflated inside the patient anatomy.The procedure was completed successfully and no clinical consequences were reported to the patient due to this event.

• Brand Name: FLOWGATE2 8F X 95CM
• Type of Device: PERCUTANEOUS CATHETER
• Manufacturer (Section D): STRYKER NEUROVASCULAR-UTAH-SALT LAKE CITY; 4870 west 2100 south; salt lake city UT 84120
• MDR Report Key: 9537086
• MDR Text Key: 198561920
• Report Number: 3012931345-2019-00112
• Device Sequence Number: 1
• Product Code: DQY
• Combination Product (y/n): N
• PMA/PMN Number: K153729
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Type of Report: Initial,Followup
• Report Date: 03/30/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/31/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 11/12/2020
• Device Catalogue Number: 90495
• Device Lot Number: 18081
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/03/2020
• Date Manufacturer Received: 03/30/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: TRANSEND EX FLOPPY GUIDE WIRE (STRYKER)