MAUDE Adverse Event Report: STRYKER NEUROVASCULAR-CALIF AXS INFINITY LS PLUS LONG SHEATH (70CM); CATHETER, PERCUTANEOUS

Catalog Number	INC-11196-70
Medical Device Problem Codes	Break (1069); Fluid/Blood Leak (1250)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	01/04/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Device not returned.
Event or Problem Description
It was reported that when the physician was trying to advance the subject catheter into the internal carotid artery (ica), the catheter sprung a leak and then broke while about 1 inch of the catheter sticking out of the patient.There were no clinical consequences reported due to this event.
Additional Manufacturer Narrative
Although the device history record (dhr) review could not be reviewed because the bath remained unknown, there are controls in the manufacturing process to ensure the product met specifications upon release.The subject device was not returned for analysis; therefore, visual, dimensional and functional testing could not be performed.In case of this complaint, the device was confirmed to be in a good condition prior to the procedure, the device was prepared as per direction for use (dfu), a continuous flush was maintained, and no resistance was encountered when advancing the catheter into the internal carotid artery (ica).While there are a number of potential causes for the reported issues, because review of available information failed to identify a definitive cause and because the product was not returned for analysis, an assignable cause of undetermined was assigned to the as reported issues 'nv - guide catheter shaft broken/fractured inside patient' and 'nv - guide catheter shaft leak inside patient'.
Event or Problem Description
It was reported that when the physician was trying to advance the subject catheter into the internal carotid artery (ica), the catheter sprung a leak and then broke while about 1 inch of the catheter sticking out of the patient.There were no clinical consequences reported due to this event.

• Brand Name: AXS INFINITY LS PLUS LONG SHEATH (70CM)
• Common Device Name: CATHETER, PERCUTANEOUS
• Manufacturer (Section D): STRYKER NEUROVASCULAR-CALIF; 47900 bayside parkway; fremont CA 94538
• MDR Report Key: 8295157
• Report Number: 3008853977-2019-00013
• Device Sequence Number: 11063559
• Product Code: DQY
• UDI-Device Identifier: 07613327459180
• UDI-Public: 07613327459180
• Combination Product (Y/N): N
• Initial Reporter State: CA
• 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): 02/22/2019

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 Catalogue Number: INC-11196-70
• Device Lot Number: N/A
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 01/06/2019
• Supplement Date Received by Manufacturer: 02/07/2019
• Initial Report FDA Received Date: 01/31/2019
• Supplement Report FDA Received Date: 02/22/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1