MAUDE Adverse Event Report: STRYKER NEUROVASCULAR-CALIF AXS INFINITY LS PLUS 90CM - US; CATHETER, PERCUTANEOUS

Model Number	INC-11196-90
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Codes	No Consequences Or Impact To Patient (2199); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/18/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Device is not available to manufacturer.
Event or Problem Description
It was reported that during the procedure, the proximal end of the catheter (subject device) shaft broke when the physician used femoral side as the access point.All the fractured parts of the subject catheter were removed successfully from the patient's anatomy.The physician replaced it with a new device and continued the procedure without clinical consequences to the patient.
Additional Manufacturer Narrative
H4 manufacturing date ¿ added.D4 expiration date - added.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 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.Additional information provided by the customer indicated that resistance was felt in the ica which was reported to be very tortuous and the reported proximal shaft fracture occurred while climbing into the ica.Based on this information, it is most likely that the catheter fractured due to manipulation against resistance during the procedure.An assignable cause of procedural factors will be assigned to the reported complaint since this issue 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 and/or anatomical factors during use.
Event or Problem Description
It was reported that during the procedure, the proximal end of the catheter (subject device) shaft broke when the physician used femoral side as the access point.All the fractured parts of the subject catheter were removed successfully from the patient's anatomy.The physician replaced it with a new device and continued the procedure without clinical consequences to the patient.

• Brand Name: AXS INFINITY LS PLUS 90CM - US
• Common Device Name: CATHETER, PERCUTANEOUS
• Manufacturer (Section D): STRYKER NEUROVASCULAR-CALIF; 47900 bayside parkway; fremont CA 94538
• MDR Report Key: 10239485
• Report Number: 3008853977-2020-00021
• Device Sequence Number: 16854438
• Product Code: DQY
• UDI-Device Identifier: 07613327459203
• UDI-Public: 07613327459203
• Combination Product (Y/N): N
• Initial Reporter State: AL
• Initial Reporter Country: US
• PMA/510(K) Number: K152876
• 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): 10/07/2020

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: 03/03/2023
• Device Model Number: INC-11196-90
• Device Catalogue Number: INC-11196-90
• Device Lot Number: 14934-01
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 06/19/2020
• Supplement Date Received by Manufacturer: 09/17/2020
• Initial Report FDA Received Date: 07/07/2020
• Supplement Report FDA Received Date: 10/07/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1