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

Model Number	90485
Medical Device Problem Code	Leak/Splash (1354)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/13/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The subject device is unavailable to manufacturer.
Event or Problem Description
It was reported that the subject device balloon catheter was used for cas (carotid artery stenting) treatment.There was no problem at the time of preparation, and it was used in the patient¿s body.Despite the injection of contrast medium during inflation, fluoroscopy did not confirm the expansion of the subject balloon.Since the occlusion was confirmed, the physician continued to use it and the procedure was completed successfully.A large amount of blood was confirmed in the subject balloon after collection.Since there was no leakage from the subject balloon, it is considered that it may have flowed in from the inner.It is probable that the reason why the fluoroscopy was not visible was that the inside of the subject balloon was filled with blood.No other information was provided.
Event or Problem Description
It was reported that the subject device balloon catheter was used for cas (carotid artery stenting) treatment.There was no problem at the time of preparation, and it was used in the patient¿s body.Despite the injection of contrast medium during inflation, fluoroscopy did not confirm the expansion of the subject balloon.Since the occlusion was confirmed, the physician continued to use it and the procedure was completed successfully.A large amount of blood was confirmed in the subject balloon after collection.Since there was no leakage from the subject balloon, it is considered that it may have flowed in from the inner.It is probable that the reason why the fluoroscopy was not visible was that the inside of the subject balloon was filled with blood.No other information was provided.
Additional Manufacturer Narrative
Section b1 product problem: corrected - remove product problem.Section h1: type of reportable event: corrected - remove malfunction.D4 expiration date - added.D9 product available to stryker ¿ updated.D9 returned to manufacturer on ¿updated.H3 device evaluated by mfg ¿updated.H3 summary attached - updated.H4 manufacturing date ¿ added.Based on the results of the device history record (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.Visual and microscopic examination of the returned device found that the balloon catheter was found to be damage.The inflation testing showed no leaks or perforations noted to the balloon or to the balloon catheter shaft or between the inflation lumen and the guidewire lumen, therefore the reported event was not confirmed during the device analysis.The device failed to meet specification when returned for analysis.There was traces of blood noted within the inflated balloon, however it cannot be determined how the blood entered the balloon, it is possible that the inflation syringe may have been re-used and may have contained blood, however this cannot be definitively determined.Blood within the balloon during the clinical procedure is likely to have caused visualization of the balloon under fluoroscopy, which may have been perceived as the balloon being leaked.An assignable cause of not confirmed will be assigned to the reported ' balloon catheter shaft leaked during use' and ' balloon failed to inflate', as the issue included a returned product review (visual, physical, and/or performance testing) which showed no evidence of either the alleged issue(s) or any defect which could have contributed to the event.It is probable that the balloon catheter was damaged during the clinical procedure, which may also have contributed to the failure to inflate the balloon.An assignable cause of procedural factors will be assigned to the analysed 'balloon catheter damaged.The manufacturer has reviewed all information and determined this event no longer meets the requirement of the reportable event for the device in question.

• 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: 12290650
• Report Number: 3012931345-2021-00129
• Device Sequence Number: 11930209
• 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): 12/23/2021

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
• Operator of Device: Health Professional
• Device Expiration Date: 10/27/2022
• Device Model Number: 90485
• Device Catalogue Number: 90485
• Device Lot Number: 0000053691
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/19/2021
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 07/14/2021
• Supplement Date Received by Manufacturer: 11/30/2021
• Initial Report FDA Received Date: 08/06/2021
• Supplement Report FDA Received Date: 12/23/2021
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/28/2020
• 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