MAUDE Adverse Event Report: STRYKER NEUROVASCULAR CORK AXS CATALYST 6 - 060X132 (FDA); CATHETER, PERCUTEANEOUS

Catalog Number	M003IC0601320
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Codes	No Known Impact Or Consequence To Patient (2692); Device Embedded In Tissue or Plaque (3165)
Date of Event	09/10/2018
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that during procedure, the tip of the catheter was fractured and moved to the external carotid artery.No additional information was provided.
Additional Manufacturer Narrative
The device history record (dhr) review confirms that the device met all material, assembly and performance specifications.During visual inspection, the entire catheter shaft was found bent.The shaft was kinked 10cm from the proximal end.The radiopaque (ro) marker was missing from the distal tip of the catheter and the distal tip was broken, confirming the reported issue.In case of this complaint, there were no anomalies noted to the catheter during preparation, the device was prepared as per direction for use (dfu), and the patient¿s the patient¿s internal carotid artery (ica) was noted to be tortuous.From the damage noted to the device, it is evident that there were difficulties encountered during the clinical procedure causing the ro marker to detach from the distal tip.It is probable that the tortuosity of the patient¿s anatomy causes the as reported event; therefore, an assignable cause of procedural factors was assigned to the as reported issues ' nv - dac shaft broken/fractured', and 'nv ¿ unexpected movement of device' and to the as analyzed issues 'nv - dac tip damaged','nv ¿ catheter ro marker missing', ' nv ¿ dac shaft damaged'as the issues are associated with a product that meets stryker design and manufacture specification 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 the procedure, the tip of the catheter (subject device) was fractured and moved into the external carotid artery.The fractured part of the catheter was removed form the patient's anatomy.The clot was not fully removed from the patient.The procedure was completed to the extent of the physician satisfaction.There were not clinical consequences to the patient reported due to this event.
Additional Manufacturer Narrative
The device history record (dhr) review confirms that the device met all material, assembly and performance specifications.During visual inspection, the entire catheter shaft was found bent.The shaft was kinked 10cm from the proximal end.The radiopaque (ro) marker was missing from the distal tip of the catheter and the distal tip was broken, confirming the reported issue.Functional testing was not performed as the defect was visually confirmed.In case of this complaint, there were no anomalies noted to the catheter during preparation, the device was prepared as per the direction for use (dfu), and the patient¿s anatomy was noted to be tortuous.From the damage noted to the device, it is evident that there were difficulties encountered during the clinical procedure causing the ro marker to detach from the distal tip.It is probable that the tortuosity of the patient¿s anatomy causes the as reported event; therefore, an assignable cause of procedural factors was assigned to the as reported issues ' nv - dac distal tip detached/separated ', and 'nv ¿ unretrieved device fragments' and to the as analyzed issues 'nv ¿ dac shaft kinked/ bent', 'nv ¿ dac distal tip detached/separated', and 'nv ¿ catheter ro marker missing', as the issues are associated with a product that meets stryker design and manufacture specification 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 the procedure, the tip of the catheter (subject device) was fractured and moved into the external carotid artery.The clot was not fully removed from the patient.The procedure was completed to the extent of the physician satisfaction.There were not clinical consequences to the patient reported due to this event.

• Brand Name: AXS CATALYST 6 - 060X132 (FDA)
• Common Device Name: CATHETER, PERCUTEANEOUS
• Manufacturer (Section D): STRYKER NEUROVASCULAR CORK; ida industrial estate; model farm road; cork NA
• MDR Report Key: 7943455
• Report Number: 3008881809-2018-00436
• Device Sequence Number: 16560242
• 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: K151667
• 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,Followup
• Report Date (Section B): 01/24/2019

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: 11/30/2019
• Device Catalogue Number: M003IC0601320
• Device Lot Number: 20161330
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/27/2018
• Initial Date Received by Manufacturer: 09/10/2018
• Supplement Date Received by Manufacturer: 11/28/2018; 12/28/2018
• Initial Report FDA Received Date: 10/08/2018
• Supplement Report FDA Received Date: 12/18/2018; 01/24/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Age: 78 YR