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

Catalog Number	90495
Medical Device Problem Codes	Fluid/Blood Leak (1250); Material Puncture/Hole (1504)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/13/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during an embolization surgery for nasopharyngeal carcinoma, the physician selected subject balloon catheter for blood flow occlusion.After delivering the subject balloon catheter to the proximal end of lesion, the physician used a 2 ml syringe for inflation.It was found that the contrast agent dispersed at the distal end of the subject balloon, and it could not inflate.The physician then withdrew the subject balloon catheter and tried inflating it.Upon inspection, it was discovered that the body of subject balloon was perforated, and the liquid was ejecting out from the tip of it.The subject device 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 an embolization surgery for nasopharyngeal carcinoma, the physician selected subject balloon catheter for blood flow occlusion.After delivering the subject balloon catheter to the proximal end of lesion, the physician used a 2 ml syringe for inflation.It was found that the contrast agent dispersed at the distal end of the subject balloon, and it could not inflate.The physician then withdrew the subject balloon catheter and tried inflating it.Upon inspection, it was discovered that the body of subject balloon was perforated, and the liquid was ejecting out from the tip of it.The subject device was replaced, and the procedure was completed successfully.No clinical consequences were reported to the patient due to this event.
Additional Manufacturer Narrative
D9 product available to stryker: updated.D9 returned to manufacturer on: updated.H3 device evaluated by mfg: updated.There are controls in the manufacturing process to ensure the product met specifications upon release.During visual inspection, it was observed that the balloon catheter was found to be kinked/bent in multiple areas.The balloon catheter was found to be damaged (wrinkled) and the balloon was found to be perforated.During functional inspection it was observed that the balloon could not be inflated during the test due to leak.The reported event is covered in the device direction 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 of the balloon leaked during use, balloon difficult to inflate and balloon has hole /perforation during use were confirmed during functional testing.The analysis results are consistent with the reported event.The returned device did not meet specifications when received for complaint investigation based on the analyzed anomalies noted to the device.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.Addition information received indicated that the device was prepared for use as per the directions for use.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.In addition, the balloon was successfully inflated and deflated during preparation.It was reported that 'after delivering the subject balloon catheter to the proximal end of the lesion, the physician used a 2ml syringe for inflation.It was found that the contrast agent dispersed at the distal end of the balloon, and the balloon could not be inflated.The physician withdrew the subject balloon catheter of the body and inflated the balloon with a syringe outside the body for inspection.It was discovered that the balloon body was perforated, with liquid ejecting out'.Follow-up information form the customer also referenced a 2ml syringe being used to inflate the balloon.The dfu recommends that a 1ml syringe with volume is 0.6ml is recommended balloon inflation volume.It was also stated that the device was not inflated over nominal pressure.The balloon catheter shaft was noted to be kinked/bent at several locations along its length.In addition, the shaft was also damaged (wrinkles present).A product condition update was provided which stated that when the product was being packed for return to the complaints lab, the catheter shaft was kinked at several locations.During functional testing it was possible to straighten out the catheter shaft and water was noted to be leaking from a perforation in the balloon.The as reported event as well and analyzed damage of balloon leaked during use, balloon difficult to inflate and balloon has hole /perforation during use and as analyzed damage of balloon catheter kinked/bent, balloon catheter damaged will be assigned procedural factors as this complaint appears to be associated with a product that met company¿s design and manufacturing specifications and appears to have been 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: 21808676
• Report Number: 3012931345-2025-00072
• Device Sequence Number: 18034680
• Product Code: DQY
• UDI-Device Identifier: 00815742004953
• UDI-Public: (01)00815742004953(17)260304(10)0000630242
• 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): 06/26/2025

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: 03/04/2026
• Device Catalogue Number: 90495
• Device Lot Number: 0000630242
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 03/17/2025
• Supplement Date Received by Manufacturer: 06/05/2025
• Initial Report FDA Received Date: 04/09/2025
• Supplement Report FDA Received Date: 06/26/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/05/2024
• 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
• Concomitant Medical Products and Therapy/Usage Dates: GUIDEWIRE_1 (UNKNOWN MANUFACTURER); GUIDEWIRE_2 (UNKNOWN MANUFACTURER); SHORT SHEATH (UNKNOWN MANUFACTURER)
• Patient Sex: Female
• Patient Weight: 42 KG
• Patient Race: Asian