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 Consequences Or Impact To Patient (2199)

Event Date 07/12/2020

Event Type  malfunction  

Manufacturer Narrative

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 device was received and there was no packaging returned with the device.On visual inspection, there was blood noted within the hub of the device indicating use.There were skive marks/damage noted to the balloon catheter shaft 46cm from the proximal end to the distal end.There was wrinkling noted to the outer surface of the balloon catheter.On functional testing, the device was flushed through the flush lumen without difficulty.An attempt was made to inflate the balloon through the inflation lumen and a leak was noted through a hole in the balloon catheter shaft at 46cm from the proximal end.The balloon would not inflate.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.Additional information provided by the customer indicated that the device was confirmed to be in good condition during preparation/prior to use on the patient and was prepared as per the dfu, continuous flush was maintained throughout the clinical procedure, and the procedure was completed with another flowgate device.During analysis, blood was observed in the hub of the device indicating use.There were skive marks/damage noted to the balloon catheter shaft from 46cm from the proximal end to the distal end.There was also wrinkling noted to the outer surface of the shaft.The device was flushed through the flush lumen without difficulty.A leak was noticed through a hole in the balloon catheter shaft at 46cm from the proximal end when an attempt was made to inflate the balloon through the inflation lumen.Due to the leak, the balloon could not be inflated during functional testing.Based on the investigation, the reported event was confirmed.An assignable cause of procedural factors will be assigned to the as reported and as analyzed balloon failed to inflate, as well as the as analyzed balloon catheter damaged, balloon shaft leaked during use, and catheter shaft has hole/perforation since these issues appear to be associated with a product that met stryker design and manufacturing specifications and was used in accordance with the dfu, but performance was limited due to procedural and/or anatomical factors during use.An assignable cause of not confirmed will be assigned to the as reported balloon catheter hub leaked since it was confirmed from the investigation that the leak occurred on the proximal shaft and not the hub.

Event Description

It was reported that during the procedure, the subject balloon catheter was unable to inflate.The physician saw contrast/saline flowing out of the proximal part of the subject balloon catheter.On investigation outside the patient anatomy, a wrenched area was seen on the subject balloon catheter.After a thirty minute surgical delay, the physician replaced the device with another one and continued the procedure without clinical consequence to the patient.The subject balloon guide catheter was returned for analysis and it was discovered that the balloon catheter shaft leaked during use and catheter shaft had hole/perforation.

• 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: 10492348
• MDR Text Key: 205647318
• Report Number: 3012931345-2020-00129
• Device Sequence Number: 1
• Product Code: DQY
• UDI-Device Identifier: 00815742004953
• UDI-Public: 00815742004953
• Combination Product (y/n): N
• Reporter Country Code: DE
• 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: 09/04/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/04/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 90495
• Device Catalogue Number: 90495
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/28/2020
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/24/2020
• Was Device Evaluated by Manufacturer?: Yes
• 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