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

Model Number 90495

Device Problems Fluid/Blood Leak (1250); Material Puncture/Hole (1504)

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

Event Date 03/18/2021

Event Type  malfunction  

Manufacturer Narrative

Device not returned for evaluation.

Event Description

It was reported that during balloon occlusion for carotid stenting in moderately tortuous anatomy, the balloon (subject device) was slowly leaking contrast during the procedure.The procedure was completed successfully as the subject balloon was able to maintain inflation for approximately 3 minutes.When the device was removed, the subject balloon had a defect at the distal edge.There were no clinical consequences reported to the patient due to this event.

Event Description

It was reported that during balloon occlusion for carotid stenting in moderately tortuous anatomy, the balloon (subject device) was slowly leaking contrast during the procedure.The procedure was completed successfully as the subject balloon was able to maintain inflation for approximately 3 minutes.When the device was removed, the subject balloon had a defect at the distal edge.There were no clinical consequences reported to the patient due to this event.

Manufacturer Narrative

The subject device is not available; therefore, visual and functional testing as well as physical analysis cannot be performed.The reported complaint could not be confirmed, and it could not be definitively determined if the device failed to meet specifications because the product was not returned.Although the dhr could not be reviewed because the lot number remains unknown, there are controls in the manufacturing process to ensure the product met specifications upon release.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 device was not returned for analysis, therefore the reported event could not be confirmed.Additional information provided by the customer indicated that the device was prepared as per the dfu, the device was confirmed to be in good condition during preparation/prior to use on the patient and continuous flush set up and maintained throughout the clinical procedure.The patients anatomy was moderately tortuous.An assignable cause of undeterminable will be assigned to the reported complaint, as, the product was not returned and review and analysis of all available information fails to indicate an assignable cause or probable assignable cause.H3 other text: device not returned for evaluation.

• 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
• MDR Report Key: 11638961
• MDR Text Key: 247226564
• Report Number: 3012931345-2021-00061
• Device Sequence Number: 1
• Product Code: DQY
• UDI-Device Identifier: 00815742004953
• UDI-Public: 00815742004953
• 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: 06/29/2021

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: 08/11/2022
• Device Model Number: 90495
• Device Catalogue Number: 90495
• Device Lot Number: 0000049885
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 03/18/2021
• Initial Date FDA Received: 04/08/2021
• Supplement Dates Manufacturer Received: 06/18/2021
• Supplement Dates FDA Received: 06/29/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1