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

Model Number	90495
Medical Device Problem Code	Failure to Unfold or Unwrap (1669)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/23/2022
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during an internal carotid artery (ica) acute occlusion case, physician inflated the balloon of the subject balloon catheter and used a stent for the thrombectomy procedure.He tried to deflate the balloon, however the balloon could not be deflated and retracted out.Physician used some force and was able to withdraw the subject balloon catheter.The balloon was inflated on the table but it was unable to be deflated.The procedure was completed successfully.No clinical consequences were reported to the patient due to this event.
Additional Manufacturer Narrative
Due to the automated manufacturing execution system (mes) there are controls in the manufacturing process to ensure the product met specifications upon release.During the visual inspection: the balloon catheter was found to be kinked/bent.The balloon catheter was found to be damaged.The balloon was found to be intact.During the functional inspection: the balloon difficult/unable to deflate functional test ¿ pass.The balloon could be inflated and deflated without difficulties.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 balloon difficult/unable to deflate was not confirmed during the analysis, however the damage noted is likely to have caused failure to deflate during use.The device failed to meet specification when returned, based on the damage noted.It was reported that used balloon guide catheter to support and used contrast agent and saline mixture to inflate the balloon and then used stent to do thrombectomy.Then deflated the balloon, however the balloon could not be deflated and the balloon could not be retracted out.Finally withdrew the balloon out with big force and inflated it on the table to try again, but the balloon was still not able to be deflated.Additional information states that the device was prepared for use as per the directions for use, the device was confirmed to be in good condition during preparation/prior to use on the patient, continuous flush set up and maintained throughout the clinical procedure and the patients anatomy was moderately tortuous.The device was returned and the balloon catheter was noted to be kinked and damaged (wrinkled) in numerous locations, the balloon was able to be inflated and deflated without difficulty.It is probable that the balloon catheter was damaged during advancement causing the reported deflation difficulty, as the damage noted is known to cause failure to, or delayed deflation times.An assignable cause of procedural factors will be assigned to reported - balloon difficult/unable to deflate during use and to the analyzed analyzed - balloon catheter kinked/bent and ¿ balloon catheter damaged, 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.
Event or Problem Description
It was reported that during an internal carotid artery (ica) acute occlusion case, physician inflated the balloon of the subject balloon catheter and used a stent for the thrombectomy procedure.He tried to deflate the balloon, however the balloon could not be deflated and retracted out.Physician used some force and was able to withdraw the subject balloon catheter.The balloon was inflated on the table but it was unable to be deflated.The procedure was completed successfully.No clinical consequences were reported to the patient due to this event.

• Brand Name: FLOWGATE2 8F X 95CM
• 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: 15620417
• Report Number: 3012931345-2022-00188
• Device Sequence Number: 6202154
• Product Code: DQY
• UDI-Device Identifier: 00815742004953
• UDI-Public: 00815742004953
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• 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): 12/27/2022

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: 06/02/2023
• Device Model Number: 90495
• Device Catalogue Number: 90495
• Device Lot Number: 0000065058
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/04/2022
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 09/23/2022
• Supplement Date Received by Manufacturer: 11/29/2022
• Initial Report FDA Received Date: 10/17/2022
• Supplement Report FDA Received Date: 12/27/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/03/2021
• 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
• Concomitant Medical Products and Therapy/Usage Dates: UNKNOWN STENT
• Patient Age: 65 YR
• Patient Sex: Male
• Patient Weight: 55 KG
• Patient Race: Asian