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	04/11/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Device not received for evaluation.
Event or Problem Description
It was reported that while performing a thrombectomy for a stroke in the middle cerebral artery (mca), the physician encountered difficulty removing the subject catheter after performing the first pass aspiration and had to use significant force to remove it.The subject catheter stretched and fractured near the midshaft to distal end.Patient anatomy was reported as fairly tortuous.The catheter was removed successfully from the patient and replaced with a similar device.The procedure was completed successfully with no clinical consequences to the patient.
Additional Manufacturer Narrative
H4 manufacturing date ¿ added h3 device evaluated by mfg ¿updated h3 summary attached - updated d4 expiration date - added d9 product available to stryker ¿ updated d9 returned to manufacturer on ¿updated the device was returned and the lot number was confirmed with the packaging returned with the device.During visual inspection the catheter was seen to be returned within an inifinty device.It was stuck within the infinity.The catheter was stretched and broken from the infinity's hub and was kinked bent.Functional inspection was not carried out due to damage to the catheter.Based on the results of the dhr review, there is no indication that the device, labeling or packaging failed to meet its specifications when released.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 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.Additional information provided by the customer indicated that there was no damage noted to the packaging prior to preparation of the device.There were no anomalies noted to the device after removal from the packaging or prior to preparation and the device was prepared as per the dfu.The catheter shaft was seen to be kinked bent, broken/fractured, stretched and was difficult to remove/withdraw.The as reported event of the catheter shaft broken/fractured during use, difficult to remove/withdraw, and stretched as well as the as analyzed catheter shaft kinked/bent, catheter shaft broken/fractured during use, stretched, and difficulty removing/withdrawing will be assigned procedural factors as 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 while performing a thrombectomy for a stroke in the middle cerebral artery (mca), the physician encountered difficulty removing the subject catheter after performing the first pass aspiration and had to use significant force to remove it.The subject catheter stretched and fractured near the midshaft to distal end.Patient anatomy was reported as fairly tortuous.The catheter was removed successfully from the patient and replaced with a similar device.The procedure was completed successfully with no clinical consequences to the patient.

• 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: 11770340
• Report Number: 3008853977-2021-00019
• Device Sequence Number: 3778014
• 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): 08/10/2021

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: 10/08/2023
• 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: 05/07/2021
• Initial Date Received by Manufacturer: 04/16/2021
• Supplement Date Received by Manufacturer: 07/16/2021
• Initial Report FDA Received Date: 05/04/2021
• Supplement Report FDA Received Date: 08/10/2021
• 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: INFINITY CATHETER (STRYKER); INFINITY CATHETER (STRYKER)
• Patient Age: 70 YR