MAUDE Adverse Event Report: STRYKER NEUROVASCULAR-CALIF AXS VECTA 074 CATH 132CM - US; CATHETER, THROMBUS RETRIEVER

Model Number	INC-11597-132
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/13/2021
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that aspiration thrombectomy procedure was performed for mca (middle cerebral artery) stroke (m1 segment occlusion).Aspiration was performed with aspiration catheter and pump during the first pass.When the physician tried to withdraw the subject catheter, resistance was encountered, and it was unable to be removed.Physician noted that the subject catheter would not come out as usual and the only way to remove it was with significant force.After continuing to pull on the hub of the subject catheter, it got released and came out of the proximal end of the access guide sheath, with its mid-section fractured and unraveled, as only the coil came out.The subject catheter was stuck, and the tip of the subject catheter was lodged inside the access guide sheath.Physician removed access guide sheath and subject catheter from the patient anatomy.The clot was removed in the process of removing both the access guide sheath and subject catheter.The procedure was completed successfully with no clinical consequences were reported to the patient due to this event.
Additional Manufacturer Narrative
Due to the automated mes system there are controls in the manufacturing process to ensure the product met specifications upon release.Visual/microscopic inspection: the catheter was seen to be broken/fractured at 111.7(proximal end) from the strain relief.The polymer was stretched significantly at 132cm from strain relief.The catheter was seen to be flat/crushed towards the distal end.The catheter was also seen to be kinked at 2, 3.5, 5.5 and 8.5cm from the catheter tip.Functional inspection: not carried out due to damage noted.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.A complaint was reported for catheter shaft difficulty removing/withdrawing, catheter shaft stretched, catheter jammed and catheter shaft broken/fractured during use.The reported complaint was confirmed based on analysis.The device failed to meet specifications when received for complaint investigation based on the analyzed anomalies noted to the device.The catheter was seen to be broken, flattened, kinked bent stretched.The device was sent for external testing.In summary, "it is the conclusion of this fractographic evaluation that the catheter failed through a transverse fracture that completely transected the extrusion.Cracking initiated at multiple locations around the circumference of the extrusion along the outer diameter wall.The cracking progressed radially through the extrusion wall, with some circumferential extension.The fracture surface features were indicative of an overload failure, in which stresses on the part exceeded the short-term strength of the material.Further, the fracture characteristics were indicative of the application of tensile stresses oriented axially through the catheter.A portion of the catheter immediately adjacent to the fracture exhibited severe crushing, as indicated by flattening of the extrusion and cracking within the metal helical reinforcement.This crushing occurred through compressive transverse loading and impingement, and preceded the transverse fracture.Subsequent axial loading resulted in extension and ultimately cracking of the catheter.No evidence was found to indicate inclusions or extrusion defects within the crack origins or within the entirety of the catheter extrusion.No signs of post-molding molecular degradation were evident.Further, no evidence was found to indicate chemical interaction, such as environmental stress cracking, plasticization, or chemical attack.Material aspects of the failure, such as possible contamination or molecular degradation, were not assessed as part of this evaluation.Further testing would be required to determine if material or processing factors played a role in the failures." 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 factors during use.
Event or Problem Description
It was reported that aspiration thrombectomy procedure was performed for mca (middle cerebral artery) stroke (m1 segment occlusion).Aspiration was performed with aspiration catheter and pump during the first pass.When the physician tried to withdraw the subject catheter, resistance was encountered, and it was unable to be removed.Physician noted that the subject catheter would not come out as usual and the only way to remove it was with significant force.After continuing to pull on the hub of the subject catheter, it got released and came out of the proximal end of the access guide sheath, with its mid-section fractured and unraveled, as only the coil came out.The subject catheter was stuck, and the tip of the subject catheter was lodged inside the access guide sheath.Physician removed access guide sheath and subject catheter from the patient anatomy.The clot was removed in the process of removing both the access guide sheath and subject catheter.The procedure was completed successfully with no clinical consequences were reported to the patient due to this event.

• Brand Name: AXS VECTA 074 CATH 132CM - US
• Common Device Name: CATHETER, THROMBUS RETRIEVER
• Manufacturer (Section D): STRYKER NEUROVASCULAR-CALIF; 47900 bayside parkway; fremont CA 94538
• MDR Report Key: 11962989
• Report Number: 3008853977-2021-00022
• Device Sequence Number: 4247043
• Product Code: NRY
• UDI-Device Identifier: 07613327459265
• UDI-Public: 07613327459265
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K172167
• 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): 09/16/2021

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: 07/08/2023
• Device Model Number: INC-11597-132
• Device Catalogue Number: INC-11597-132
• Device Lot Number: 15601-01
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/19/2021
• Initial Date Received by Manufacturer: 05/14/2021
• Supplement Date Received by Manufacturer: 09/14/2021
• Initial Report FDA Received Date: 06/08/2021
• Supplement Report FDA Received Date: 09/16/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: BMX SHEATH (PENUMBRA); SYNCHRO2 SOFT GUIDEWIRE (STRYKER)