MAUDE Adverse Event Report: STRYKER NEUROVASCULAR CORK AXS CATALYST 6 .060IN ID X 132CM - US; CATHETER, PERCUTANEOUS

Model Number	M003IC0601320
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	08/11/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported in a medwatch report during procedure for a venous sinus stent placement for idiopathic intracranial hypertension, severe left transverse sinus stenosis and severe right transverse/sigmoid sinus stenosis the distal tip of the subject catheter was broken off at the junction of the right internal jugular vein and sigmoid sinus.The fragment traveled to the right side of the heart, and embedded in the left lung.The fragment was not removed from the patient and the procedure was not completed.The patient required an overnight stay in the intensive care unit for monitoring, imaging, and a cardiothoracic surgery consult to plan for follow up appointments with neurosurgery for a second surgery attempt at stenting the venous sinus.The patient is currently stable.The patients anatomy was described as tortious.No other information is available.
Additional Manufacturer Narrative
Device not returned for evaluation.
Additional Manufacturer Narrative
Due to the automated manufacturing execution system (mes) system there are controls in the manufacturing process to ensure the product met specifications upon release.The subject device is not available; therefore, visual and functional testing as well as physical analysis cannot be performed.The reported complaint could not be confirmed, and it could not be definitively determined if the device failed to meet specifications because the product was not returned.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 a piece if the catheter broke off in the venous side which traveled to the right side of the heart, ultimately terminating in the left lung.Additional information provided by the customer indicated that patient required an overnight stay in the intenside care unit (icu) for monitoring.Scheduled are repeat imaging and follow up appointments with neurosurgery to plan a second attempt at stenting the venous sinus.The patient is currently stable.The patient¿s diagnosis of idiopathic intracranial hypertension with right transverse-sigmoid sinus stenosis with a pressure gradient across the stenosis is causing vision loss due to the patient¿s currently untreated condition.The device was not returned for analysis.Therefore the as reported cannot be confirmed.While there are a number of potential causes for the reported issue, because review and analysis of available information failed to identify a definitive cause, a cause of undeterminable was assigned.H3 other text : device not returned for evaluation.
Event or Problem Description
It was reported in a medwatch report during procedure for a venous sinus stent placement for idiopathic intracranial hypertension, severe left transverse sinus stenosis and severe right transverse/sigmoid sinus stenosis the distal tip of the subject catheter was broken off at the junction of the right internal jugular vein and sigmoid sinus.The fragment traveled to the right side of the heart, and embedded in the left lung.The fragment was not removed from the patient and the procedure was not completed.The patient required an overnight stay in the intensive care unit for monitoring, imaging, and a cardiothoracic surgery consult to plan for follow up appointments with neurosurgery for a second surgery attempt at stenting the venous sinus.The patient is currently stable.The patients anatomy was described as tortious.No other information is available.

• Brand Name: AXS CATALYST 6 .060IN ID X 132CM - US
• Common Device Name: CATHETER, PERCUTANEOUS
• Manufacturer (Section D): STRYKER NEUROVASCULAR CORK; ida industrial estate; model farm road; cork NA ; EI NA
• Manufacturer (Section G): STRYKER NEUROVASCULAR CORK; ida industrial estate; model farm road; cork NA ; EI NA
• Manufacturer Contact: tara lopez ; 47900 bayside parkway; fremont, CA 94538 ; 5104132500
• MDR Report Key: 15504320
• Report Number: 3008881809-2022-00471
• Device Sequence Number: 14812198
• Product Code: DQY
• UDI-Device Identifier: 07613327012033
• UDI-Public: 07613327012033
• Combination Product (Y/N): N
• Initial Reporter State: KY
• Initial Reporter Country: US
• PMA/510(K) Number: K183463
• 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): 12/19/2022

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: 02/10/2023
• Device Model Number: M003IC0601320
• Device Catalogue Number: M003IC0601320
• Device Lot Number: 22705344
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 09/02/2022
• Supplement Date Received by Manufacturer: 11/29/2022
• Initial Report FDA Received Date: 09/29/2022
• Supplement Report FDA Received Date: 12/19/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 02/11/2021
• 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
• Outcome Attributed to Adverse Event: Other
• Patient Age: 30 YR
• Patient Sex: Female