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 Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/02/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Device discarded at hospital.
Event or Problem Description
It was reported that during the procedure at access via radial artery to delivery thrombectomy devices the catheter (subject device) distal shaft was broken off inside patient.Another surgery was performed to remove the broken fragments of the catheter.The patients medical condition was good.There were no clinical consequences to the patient.
Event or Problem Description
It was reported that during the procedure at access via radial artery to delivery thrombectomy devices the catheter (subject device) distal shaft was broken off inside patient.Another surgery was performed to remove the broken fragments of the catheter.The patients medical condition was good.There were no clinical consequences to the patient.
Additional Manufacturer Narrative
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.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 could not be confirmed and it cannot be confirmed that the device met specification as the device was not returned.As the product was not returned and a review and analysis of all available information fails to indicate an assignable cause or probable assignable cause for the reported event, an assignable cause of undeterminable will be assigned to this complaint.H3 other text: device discarded at hospital.

• 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: 11083718
• Report Number: 3008853977-2020-00041
• Device Sequence Number: 3754353
• Product Code: DQY
• UDI-Device Identifier: 07613327459203
• UDI-Public: 07613327459203
• Combination Product (Y/N): N
• Initial Reporter State: IL
• 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): 02/09/2021

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: 05/23/2025
• Device Model Number: INC-11196-90
• Device Catalogue Number: INC-11196-90
• Device Lot Number: 15270-01
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 12/02/2020
• Supplement Date Received by Manufacturer: 01/19/2021
• Initial Report FDA Received Date: 12/28/2020
• Supplement Report FDA Received Date: 02/09/2021
• 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; Required Intervention