MAUDE Adverse Event Report: STRYKER NEUROVASCULAR-CALIF AXS INFINITY LS PLUS 70CM - US; CATHETER, PERCUTANEOUS

Model Number	INC-11196-70
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/07/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The subject device not returned.
Event or Problem Description
It was reported that a patient was treated for a stroke using the subject catheter.The subject catheter unraveled at the coil and began pulling away from the catheter itself.The outer sheath of the catheter was broken off.Vascular surgeon was called and assisted to ¿cut-down¿ at the radial artery to remove the catheter.All part of the catheter was removed from the patient anatomy.There were no clinical consequences reported due to this event.The patient is doing well.
Event or Problem Description
It was reported that a patient was treated for a stroke using the subject catheter.The subject catheter unraveled at the coil and began pulling away from the catheter itself.The outer sheath of the catheter was broken off.Vascular surgeon was called and assisted to ¿cut-down¿ at the radial artery to remove the catheter.All part of the catheter was removed from the patient anatomy.There were no clinical consequences reported due to this event.The patient is doing well.
Additional Manufacturer Narrative
D4 expiration date - added.H4 manufacturing 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 cannot be performed.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 device was not returned and therefore the as reported cannot be confirmed.While there are a number of potential causes for the reported issue, because review and analysis of available information failed to identify a definitive cause, a cause of undeterminable was assigned.

• Brand Name: AXS INFINITY LS PLUS 70CM - US
• Common Device Name: CATHETER, PERCUTANEOUS
• Manufacturer (Section D): STRYKER NEUROVASCULAR-CALIF; 47900 bayside parkway; fremont CA 94538
• MDR Report Key: 11115374
• Report Number: 3008853977-2021-00002
• Device Sequence Number: 11775047
• Product Code: DQY
• UDI-Device Identifier: 07613327459180
• UDI-Public: 07613327459180
• Combination Product (Y/N): N
• Initial Reporter State: TX
• 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: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 03/05/2021

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: 03/05/2023
• Device Model Number: INC-11196-70
• Device Catalogue Number: INC-11196-70
• Device Lot Number: 114934-01
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 12/08/2020
• Supplement Date Received by Manufacturer: 02/11/2021
• Initial Report FDA Received Date: 01/05/2021
• Supplement Report FDA Received Date: 03/05/2021
• 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: Required Intervention