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

Model Number	90485
Medical Device Problem Code	Material Rupture (1546)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/10/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device is not available to the manufacturer.
Event or Problem Description
It was reported that during the medical procedure, when the subject balloon was advanced to the lesion and attempted to dilate, the subject balloon ruptured.The subject balloon was replaced, and the procedure was completed successfully.No clinical consequences were reported to the patient due to this event.
Event or Problem Description
It was reported that during the medical procedure, when the subject balloon was advanced to the lesion and attempted to dilate, the subject balloon ruptured.The subject balloon was replaced, and the procedure was completed successfully.No clinical consequences were reported to the patient due to this event.
Additional Manufacturer Narrative
D4 expiration date - added.H4 manufacturing date ¿ added.Due to the automated manufacturing execution system (mes) there are controls in the manufacturing process to ensure the product met specifications upon release.The subject device is not available; therefore, functional testing as well as visual testing cannot be performed.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 could not be confirmed and it cannot be confirmed that the device met specification, as the device was not returned.It was reported that although there was no problem at the preparation of the device, the balloon of the subject device got ruptured when the catheter was advanced to the lesion and attempted to dilate the balloon.Additional information states that the balloon was able to inflate successfully during preparation, the contrast agent was diluted, a syringe was used to inflate the balloon and the patient's anatomy was very meandering.It is probable that the device may have been damaged during navigation through the patients 'very meandering' anatomy, causing the reported balloon burst/rupture.An assignable cause of procedural factors will be assigned to the reported - balloon burst/ruptured 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 85CM
• Common Device Name: 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: 15921010
• Report Number: 3012931345-2022-00220
• Device Sequence Number: 2492664
• Product Code: DQY
• UDI-Device Identifier: 00815742004854
• UDI-Public: 00815742004854
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K153729
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 12/29/2022

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
• Operator of Device: Health Professional
• Device Expiration Date: 06/12/2023
• Device Model Number: 90485
• Device Catalogue Number: 90485
• Device Lot Number: 65685
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 11/10/2022
• Supplement Date Received by Manufacturer: 12/07/2022
• Initial Report FDA Received Date: 12/05/2022
• Supplement Report FDA Received Date: 12/29/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 06/13/2021
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown