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

Model Number 90485

Device Problem Deflation Problem (1149)

Patient Problems No Consequences Or Impact To Patient (2199); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 08/04/2020

Event Type  malfunction  

Manufacturer Narrative

Subject device is not available.

Event Description

It was reported that during the procedure, the subject balloon was unable to deflate.The physician replaced with a new device and completed the procedure without any consequences to the patient.

Manufacturer Narrative

Due to the automated mes system there are controls in the manufacturing process to ensure the product met specifications upon release.The device was returned.The reported lot number was confirmed from the returned packaging.On visual inspection, 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.On visual inspection, the balloon catheter was kinked at 19cm & 26cm from the proximal end.On functional testing, an attempt was made to inflate the balloon; however, the balloon was unable to be inflated.The reported event was confirmed.The device was returned for analysis and the balloon catheter was found kinked/bent and the balloon failed to inflate.In the case of this complaint it is most likely that the device was damaged during the procedure due to some procedural/anatomical factors.This complaint appears to be associated with a product that met stryker and design and manufacturing specifications and was used in accordance with the dfu, but performance was limited due to procedural factors during use.Therefore an assignable cause of procedural factors will be assigned to the and to the as reported defect balloon difficult/unable to deflate during use and the analyzed defects balloon catheter shaft kinked/bent and balloon failed to inflate.

Event Description

It was reported that during the procedure, the subject balloon was unable to deflate.The physician replaced with a new device and completed the procedure without any consequences to the patient.

• 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
• MDR Report Key: 10465874
• MDR Text Key: 206576398
• Report Number: 3012931345-2020-00122
• Device Sequence Number: 1
• Product Code: DQY
• UDI-Device Identifier: 00815742004854
• UDI-Public: 00815742004854
• 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: 01/12/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/28/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 05/14/2021
• Device Model Number: 90485
• Device Catalogue Number: 90485
• Device Lot Number: 27079
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/07/2020
• Date Manufacturer Received: 12/18/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1