MAUDE Adverse Event Report: STRYKER NEUROVASCULAR-CALIF AXS VECTA 071 CATH 115CM - US; CATHETER, PERCUTANEOUS, NEUROVASCULATURE22

Catalog Number	INC-11129-115
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/19/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during ruptured aneurysm procedure, after the stent was removed from the microcatheter, the long sheath had prolapsed around the arch and the subject intermediate catheter was observed to be still in place in the ica (internal carotid artery).The physician removed the long sheath, microcatheter and subject intermediate catheter which was observed to be unravelling distally.Resistance was encountered removing the intermediate catheter which then unraveled the nitinol round wire coil segment of the intermediate catheter into the long sheath.The physician replaced it with a new device and continued the procedure without clinical consequences to the patient.
Event or Problem Description
It was reported that during ruptured aneurysm procedure, after the stent was removed from the microcatheter, the long sheath had prolapsed around the arch and the subject intermediate catheter was observed to be still in place in the ica (internal carotid artery).The physician removed the long sheath, microcatheter and subject intermediate catheter which was observed to be unravelling distally.Resistance was encountered removing the intermediate catheter which then unraveled the nitinol round wire coil segment of the intermediate catheter into the long sheath.The physician replaced it with a new device and continued the procedure without clinical consequences to the patient.
Additional Manufacturer Narrative
H3 device evaluated by mfg ¿updated.D2a common device name - updated.D2b product code - updated.D4 gtin - updated.D9 returned to manufacturer on - updated.D9 product available to stryker ¿ updated.G4 pma/510(k) - updated.There are controls in the manufacturing process to ensure the product met specifications upon release.The device was returned, and the lot number was not confirmed as the packaging was not returned with the device.During visual inspection, the catheter was found to be severely damaged.The catheter was found to be broken/fractured 95cm from the hub.The was a microcatheter jammed inside returned returned device.The microcatheter was removed with force.The catheter tip was found to be slightly crushed.Functional testing was not completed due to device condition.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.The catheter was returned for analysis and was found to be severely damaged.The catheter was found to be broken/fractured 95cm from the hub.The was a microcatheter jammed inside returned device.The microcatheter was removed with force.The catheter tip was found to be slightly crushed.The as reported events of catheter shaft difficulty removing/withdrawing, catheter shaft stretched and catheter shaft broken/fractured during use as well as the analyzed events of catheter shaft kinked/bent, catheter shaft stretched, catheter tip flat/crushed, catheter shaft broken/fractured during use and catheter shaft 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.

• Brand Name: AXS VECTA 071 CATH 115CM - US
• Common Device Name: CATHETER, PERCUTANEOUS, NEUROVASCULATURE22
• Manufacturer (Section D): STRYKER NEUROVASCULAR-CALIF; 47900 bayside parkway; fremont CA 94538
• Manufacturer (Section G): STRYKER NEUROVASCULAR-CALIF; 47900 bayside parkway; fremont CA 94538
• Manufacturer Contact: tara lopez ; 47900 bayside parkway; fremont, CA 94538 ; 5104132500
• MDR Report Key: 19780313
• Report Number: 3008853977-2024-00021
• Device Sequence Number: 12789899
• Product Code: QJP
• UDI-Device Identifier: 07613327459210
• UDI-Public: (01)07613327459210(17)260811(10)22369-01
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: K200206
• 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): 10/14/2024

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: 08/11/2026
• Device Catalogue Number: INC-11129-115
• Device Lot Number: 22369-01
• 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: 07/03/2024
• Supplement Date Received by Manufacturer: 09/23/2024
• Initial Report FDA Received Date: 07/19/2024
• Supplement Report FDA Received Date: 10/14/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/14/2023
• 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: NEURON MAX SHEATH (PENUMBRA); NF ATLAS STENT (STRYKER); SL-10 MICROCATHETER (STRYKER); SYNCHRO GUIDEWIRE (STRYKER); TARGET COILS (STRYKER)
• Patient Sex: Female