MAUDE Adverse Event Report: STRYKER NEUROVASCULAR-CALIF AXS INFINITY LS PLUS .091IN ID X 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	12/27/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The device is not available to the manufacturer.
Event or Problem Description
It was reported that during the procedure, the proximal end of the subject catheter was found kinked during preparation.The resistance was felt at the proximal portion of the subject catheter while advancing inside the dilator and advancing the guide catheter inside the subject catheter.After removing the occlusion from the patient anatomy, while performing a run on the target vessel the physician found the tip of the subject catheter broke inside the patient anatomy.The physician used forceps to track over a wire and retrieved the broken fragment out of the patient's anatomy.The patient is doing well and was not impacted long-term.No additional information was provided regarding the patient impact due to this event.
Event or Problem Description
It was reported that during the procedure, the proximal end of the subject catheter was found kinked during preparation.The resistance was felt at the proximal portion of the subject catheter while advancing inside the dilator and advancing the guide catheter inside the subject catheter.After removing the occlusion from the patient anatomy, while performing a run on the target vessel the physician found the tip of the subject catheter broke inside the patient anatomy.The physician used forceps to track over a wire and retrieved the broken fragment out of the patient's anatomy.The patient is doing well and was not impacted long-term.No additional information was provided regarding the patient impact due to this event.
Additional Manufacturer Narrative
H3 device evaluated by mfg ¿updated.H3 summary attached - updated.H4 manufacturing date ¿ added.D4 expiration date - added.D10 product available to stryker ¿ updated.D10 returned to manufacturer on ¿updated.The device history record (dhr) confirms that the device met all material, assembly and performance specifications.During the visual inspection, the catheter shaft was found to be kinked at 4cm and 68cm from the hub.The catheter shaft was found to be broken 7cm from the hub and there was exposed coil seen through the break on the catheter shaft.The catheter shaft was found to be damaged.The catheter tip was found to be intact.Functional testing can not be carried out due to the device was damaged.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 catheter tip was seen to be intact and therefore the as reported 'catheter tip broken/fractured during use will not be confirmed.The catheter was seen to be kinked bent and damaged and the shaft was broken/fractured.Therefore the as reported 'catheter shaft kinked bent' and 'catheter shaft friction' as well as the as analyzed 'catheter shaft broken/fractured during use', 'catheter shaft kinked bent' and 'catheter damaged' will be assigned procedural factors as it 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 INFINITY LS PLUS .091IN ID X 90CM-US
• Common Device Name: CATHETER, PERCUTANEOUS
• 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: 13333571
• Report Number: 3008853977-2022-00004
• Device Sequence Number: 20111840
• Product Code: DQY
• UDI-Device Identifier: 07613327459203
• UDI-Public: 07613327459203
• Combination Product (Y/N): N
• Initial Reporter State: NC
• 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): 04/08/2022

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: 01/20/2024
• Device Model Number: INC-11196-90
• Device Catalogue Number: INC-11196-90
• Device Lot Number: 16469-01
• 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: 12/28/2021
• Supplement Date Received by Manufacturer: 03/31/2022
• Initial Report FDA Received Date: 01/24/2022
• Supplement Report FDA Received Date: 04/08/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/22/2021
• 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: FORCEPS (UNKNOWN)
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown