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	06/28/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device is not available to the manufacturer.
Event or Problem Description
It was reported that carotid artery stenting was performed.The patient was having average tortuous vasculature.After preparing the subject balloon catheter according to dfu, when the surgeon was putting peel-away sheath over the balloon part, there was some resistance, but he was able to put it on.After advancement of the balloon into the patient vasculature, when the surgeon tried to expand the subject balloon, the balloon did not expand.So, the surgeon removed it from the body and confirmed that the balloon was torn.The physician replaced it with a new device.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 carotid artery stenting was performed.The patient was having average tortuous vasculature.After preparing the subject balloon catheter according to dfu, when the surgeon was putting peel-away sheath over the balloon part, there was some resistance, but he was able to put it on.After advancement of the balloon into the patient vasculature, when the surgeon tried to expand the subject balloon, the balloon did not expand.So, the surgeon removed it from the body and confirmed that the balloon was torn.The physician replaced it with a new device.The procedure was completed successfully.No clinical consequences were reported to the patient due to this event.
Additional Manufacturer Narrative
Based on the results of the dhr review, there is no indication that the device, labeling or packaging failed to meet its specifications when released.Visual/microscopic inspection: the balloon catheter was found to be kinked/bent.The balloon catheter was found to be damaged.The balloon was found to be leaking due to burst/rapture.Functional inspection: balloon difficult to inflate functional test ¿ fail.Balloon could not be inflated due to leakage.Balloon burst/ruptured functional test ¿ fail.Defect confirmed as the balloon could not be inflated due to leakage.Device difficulty prepping functional test ¿ pass- no difficulties to move peel away sheath over balloon and balloon catheter.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.It was reported that, after preparation, when the surgeon put the peel-away sheath over the balloon part, there was some resistance, but he was able to put it on.Then when he tried to expand the balloon, the balloon did not expand, so he removed it from the body and confirmed that the balloon was torn.As per the additional information, the balloon was inflated without problem at the time of preparation, a ¿1¿ syringe¿ was used to expand the balloon, ¿a peel-away sheath¿ was used when inserting it into the sheath.The device was returned and it was confirmed that the balloon had a hole/perforation.The balloon catheter was kinked and damaged.It is probable that the balloon was damaged as a result of the resistance experienced when the peel-away sheath was placed over the balloon, causing the reported event.An assignable cause of handling damage will be assigned to the reported device difficulty prepping, balloon difficult to inflate and balloon burst ruptured during use and to the analyzed balloon burst/ruptured during use and balloon leaked during use.It is probable that the balloon catheter was kinked and damaged during the clinical procedure.An assignable cause of procedural factors will be assigned to the analyzed balloon catheter kinked/bent, 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.

• 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: 12215530
• Report Number: 3012931345-2021-00119
• Device Sequence Number: 3036012
• 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: 05/27/2022
• Device Model Number: 90485
• Device Catalogue Number: 90485
• Device Lot Number: 46030
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/22/2021
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 06/28/2021
• Supplement Date Received by Manufacturer: 12/20/2021
• Initial Report FDA Received Date: 07/22/2021
• Supplement Report FDA Received Date: 12/23/2021
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/28/2020
• 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 Age: 87 YR
• Patient Sex: Female
• Patient Race: Asian