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	04/19/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported during an endovascular procedure the subject catheter broke inside the patient.The physician used a snare to remove the fractured subject catheter fragment resulting in an additional 30 minutes to complete the procedure.The procedure was completed successfully with no clinical consequences to the patient.
Additional Manufacturer Narrative
The device is not available to the manufacturer.
Additional Manufacturer Narrative
Event description ¿ updated.B5 executive summary - updated.C2/d10 concomitant products grid - updated.E1 initial reporter name and facility details - added.E2 health professional- added.E3 health professional occupation- added.H4 manufacturing date ¿ added.H3 device evaluated by mfg ¿updated.H3 summary attached - updated.D4 expiration date - added.D9 product available to stryker ¿ updated.D9 returned to manufacturer on ¿updated.Due to the automated manufacturing execution system (mes) there are controls in the manufacturing process to ensure the product met specifications upon release.The device was received.The reported lot number was not confirmed as the packaging was not returned with the device.During visual inspection, the catheter shaft was seen to be broken.The catheter shaft was seen to be flat/crushed.There was a large amount of blood seen in the catheter hub.There was unknown catheter and guidewire advanced through the catheter (unable to be removed due to the condition of the returned device).Functional testing was not required as the defect was confirmed during analysis.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 was confirmed based on analysis.The device failed to meet specifications when received for complaint investigation based on the analyzed anomalies noted to the device.It was reported that the catheter broke inside the patient.Doctors had to go in and snare the piece of the catheter which broke in the patient.It took an additional half hour to complete the procedure'.The presence of dried blood in the hub is an indication that insufficient flush might have been a factor in this complaint.The catheter shaft was seen to be broken.The catheter shaft was seen to be flat/crushed.There was a large amount of blood seen in the catheter hub.There was unknown catheter and guidewire advanced through the catheter (unable to be removed due to the condition of the returned device).The as reported event of catheter shaft broken/fractured during use can be confirmed based on the analysis and the as reported as well as the as analyzed event of catheter shaft broken/fractured during use and the as analyzed event of catheter shaft flat/crushed will be assigned procedural factors as this complaint 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.
Event or Problem Description
It was reported during an endovascular procedure the subject catheter broke inside the patient.The physician used a snare to remove the fractured subject catheter fragment resulting in an additional 30 minutes to complete the procedure.The procedure was completed successfully with no clinical consequences to the patient.Updated information: based on additional information obtained on 20 may 2022 it was reported that during an endovascular procedure in a patient with stroke at m1 segment of middle cerebral artery, the subject catheter broke at femoral.Physician used a balloon to retrieve the fractured subject catheter fragment out of the patient vasculature resulting in an additional 30 minutes to complete the procedure.The procedure was completed successfully with no clinical consequences to the patient.

• 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: 14380757
• Report Number: 3008853977-2022-00020
• Device Sequence Number: 17362095
• Product Code: DQY
• UDI-Device Identifier: 07613327459203
• UDI-Public: 07613327459203
• Combination Product (Y/N): N
• Initial Reporter State: GA
• 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): 07/29/2022

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: 08/28/2024
• Device Model Number: INC-11196-90
• Device Catalogue Number: INC-11196-90
• Device Lot Number: 18015-01
• 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: 04/19/2022
• Supplement Date Received by Manufacturer: 07/06/2022
• Initial Report FDA Received Date: 05/12/2022
• Supplement Report FDA Received Date: 07/29/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/31/2021
• 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: PERIPHERAL BALLOON (UNKNOWN); SNARE (UNKNOWN)
• Outcome Attributed to Adverse Event: Other; Required Intervention
• Patient Sex: Unknown