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

Catalog Number	90495
Medical Device Problem Code	Deflation Problem (1149)
Health Effect - Clinical Codes	Hemorrhage/Blood Loss/Bleeding (1888); Perforation (2001)
Date of Event	03/04/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the subject balloon was used in the pulmonary procedure, however when the physician attempted to deflate the subject balloon, he couldn't manage to deflate it thus the subject balloon was retracted and removed from the patient's body in the inflated state.A delay of 30 minutes was reported in the procedure with extended anesthesia, perforation and bleeding due to the reported event.No further information available.
Event or Problem Description
It was reported that the subject balloon was used in the pulmonary procedure, however when the physician attempted to deflate the subject balloon, he couldn't manage to deflate it thus the subject balloon was retracted and removed from the patient's body in the inflated state.A delay of 30 minutes was reported in the procedure with extended anesthesia, perforation and bleeding due to the reported event.No further information available.
Additional Manufacturer Narrative
D9 product available to stryker - updated.D9 returned to manufacturer on - added.H3 device evaluated by mfg - updated.There are controls in the manufacturing process to ensure the product met specifications upon release.During visual inspection, the balloon catheter was found to be severely kinked/bent at multiple points along its length.It was also flattened at multiple points.The damage was noted approximately 15cm, 31cm, 46cm, 56cm, 71cm and 86cm from the proximal end of the device.There was dried procedural present in the lumen of the balloon catheter shaft which extended back as far as the catheter hub.The balloon catheter appeared to be undamaged at the balloon area and at the distal tip.During functional inspection, the balloon could not be inflated during the test due to significant damage noted to the balloon catheter shaft.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 as reported ¿balloon difficult/unable to deflate during use' was confirmed during analysis.The analysis results are consistent with the reported events.The device did not meet specifications when received for complaint investigation based on visual inspection.Additional information provided by the customer indicated that the device was prepared as per the dfu.There was no damage noted to the packaging prior to opening the packaging and the device was confirmed to be in good condition prior to use on the patient.Continuous flush was set up and maintained throughout the clinical procedure and the patients anatomy was described as 'moderately tortuous'.It was reported that 'during the procedure, when the physician wanted to deflate the balloon, he couldn't manage to deflate it.The balloon has been retracted in an inflated state and could be completely removed from the patient eventually'.In the follow-up good faith efforts (gfe) responses it was reported that there were adverse consequences for the patient.In addition to a 30 minute delay experienced, anesthesia had to be extended and there was bleeding due to a perforation which was necessary to make.The device was returned and the balloon catheter was noted to be severely kinked/bent and flattened in multiple locations along the balloon catheter length.Given that the dfu instructions were followed, this means that the balloon was successfully inflated and deflated during preparation.Therefore, it is probable that the device was somehow damaged following initial preparation, causing the reported event.This type of failure occurs when there is a kink or obstruction in the shaft or the balloon is somehow prevented from deflating.Based on the review of all available information, an assignable cause of procedural factors has been assigned to the as reported 'balloon difficult/unable to deflate during use'.The remaining as reported ¿patient vessel perforation¿, ¿patient hemorrhage, blood loss without sequelae¿ will be assigned anticipated procedural complication.While the reported vessel perforation and hemorrhage are anticipated outcomes from these type of procedure, in this case it can most likely be attributed to the attempt to withdraw the inflated balloon.The as analysed ¿balloon catheter kinked/bent¿, ¿balloon catheter damaged¿, ¿balloon catheter flat/crushed¿ and ¿balloon difficult to inflate¿ will also be assigned procedural factors.This complaint appears 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.

• 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: 21708200
• Report Number: 3012931345-2025-00068
• Device Sequence Number: 21334706
• Product Code: DQY
• UDI-Device Identifier: 00815742004953
• UDI-Public: (01)00815742004953(17)260805(10)0000704619
• Combination Product (Y/N): N
• Initial Reporter Country: SZ
• 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): 06/10/2025

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 08/05/2026
• Device Catalogue Number: 90495
• Device Lot Number: 0000704619
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 03/04/2025
• Supplement Date Received by Manufacturer: 05/21/2025
• Initial Report FDA Received Date: 03/27/2025
• Supplement Report FDA Received Date: 06/10/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/06/2024
• 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
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown