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 Codes	Fracture (1260); Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Hemorrhage/Blood Loss/Bleeding (1888)
Date of Event	10/08/2020
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that during a pca the catheter (subject device) separated from the sheath and was broken.The physician clamped the subject catheter to stop blood loss.All broken fragments were removed from the patient.The procedure was completed successfully.There were no clinical consequences to the patient.
Event or Problem Description
It was reported that during a pca the catheter (subject device) separated from the sheath and was broken.The physician clamped the subject catheter to stop blood loss.All broken fragments were removed from the patient.The procedure was completed successfully.There were no clinical consequences to the patient.
Additional Manufacturer Narrative
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.The device was returned without packaging, therefore the lot number could not be confirmed.During visual inspection the catheter was seen to be extremely damaged including flattening and breakages throughout the catheter.Functional inspection was not carried out due to the damage of the device.Due to the automated mes system there are controls in the manufacturing process to ensure the product met specifications upon release.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.The catheter was seen to be extremely damaged.The catheter shaft was seen to be broken fractured, this was caused by the clamping of the catheter which occurred.The catheter shaft was seen to be flat/crushed also.The reported event will be assigned procedural factors as this event 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
• MDR Report Key: 10775420
• Report Number: 3008881809-2020-00328
• Device Sequence Number: 13734772
• Product Code: DQY
• UDI-Device Identifier: 07613327459203
• UDI-Public: 07613327459203
• Combination Product (Y/N): N
• Initial Reporter State: FL
• 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): 05/03/2021

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: 05/11/2023
• Device Model Number: INC-11196-90
• Device Catalogue Number: INC-11196-90
• Device Lot Number: 15217-01
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/19/2020
• Initial Date Received by Manufacturer: 10/08/2020
• Supplement Date Received by Manufacturer: 04/26/2021
• Initial Report FDA Received Date: 11/02/2020
• Supplement Report FDA Received Date: 05/03/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: CLAMP (UNKNOWN).; CLAMP (UNKNOWN)
• Outcome Attributed to Adverse Event: Other; Required Intervention