MAUDE Adverse Event Report: STRYKER NEUROVASCULAR CORK AXS OFFSET CATH .050IN ID X 150CM - US; PERCUTANEOUS CATHETER

Model Number	M003DC050150A0
Medical Device Problem Code	Component Missing (2306)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/04/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Device is not available to manufacturer.
Event or Problem Description
It was reported that the subject catheter's radio opaque marker detached during procedure.No clinical consequences were reported to the patient due to this event.
Additional Manufacturer Narrative
Due to the automated manufacturing execution system (mes), there are controls in the manufacturing process to ensure the product met specifications upon release.The reported lot number was confirmed from the returned packaging.On visual inspection, there were no anomalies noted to the cat 5.There were no anomalies noted to the axs offset catheter and the radio opaque (ro) marker was present.Dimensional and functional inspection were not required as the defect was not confirmed.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 available information states that there was a marker band found detached within the axs catalyst 5 catheter, it could not be determined which device it was from.The device was returned and it was confirmed to meet specification, there was no evidence of damage or a missing ro marker band.An assignable cause of not confirmed will be assigned to the reported ro marker(s) detached/separated/not visible under fluoroscopy and device interaction with another device, as the issue included a returned product review (visual, physical, and/or performance testing) which showed no evidence of either the alleged issue(s) or any defect which could have contributed to the event.The manufacturer has reviewed all information and determined this event no longer meets the requirement of the reportable event for the device in question.
Event or Problem Description
It was reported that the subject catheter's radio opaque (ro) marker detached during procedure.No clinical consequences were reported to the patient due to this event.

• Brand Name: AXS OFFSET CATH .050IN ID X 150CM - US
• Common Device Name: PERCUTANEOUS CATHETER
• Manufacturer (Section D): STRYKER NEUROVASCULAR CORK; ida industrial estate; model farm road; cork NA ; EI NA
• MDR Report Key: 10937051
• Report Number: 3008881809-2020-00374
• Device Sequence Number: 3234681
• Product Code: DQY
• UDI-Device Identifier: 07613327361155
• UDI-Public: 07613327361155
• Combination Product (Y/N): N
• Initial Reporter State: NH
• Initial Reporter Country: US
• PMA/510(K) Number: K163259
• 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): 02/16/2021

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 Expiration Date: 12/09/2021
• Device Model Number: M003DC050150A0
• Device Catalogue Number: M003DC050150A0
• Device Lot Number: 22010096
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/16/2020
• Initial Date Received by Manufacturer: 11/04/2020
• Supplement Date Received by Manufacturer: 01/25/2021
• Initial Report FDA Received Date: 12/02/2020
• Supplement Report FDA Received Date: 02/16/2021
• 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: SURPASS FLOW DIVERTER (STRYKER); SYNCHRO GUIDEWIRE (STRYKER); TRANSFORM BALLOON (STRYKER)