MAUDE Adverse Event Report: STRYKER NEUROVASCULAR CORK AXS CATALYST 5 .058IN ID X 132CM - US; CATHETER, PERCUTANEOUS

Model Number	M003IC0581320
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/26/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Due to the automated mes (manufacturing execution system) system there are controls in the manufacturing process to ensure the product met specifications upon release.During visual inspection, the catheter shaft was seen to be broken and the nitnol was exposed and tangled, the nitnol snapped during analysis in an attempt to try and untangle it, the catheter shaft was seen to be stretched and damaged.A functional test was not carried out due to the break on the shaft.The reported complaint was confirmed based on the damage noted to the device during analysis.The device failed to meet specification when received for complaint investigation based on the analyzed anomalies noted to the device.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 shaft was seen to be broken and the nitinol was exposed and tangled, and catheter shaft was seen to be stretched, and therefore the as reported can be confirmed.The as reported ar as well as the as analyzed aa, 'catheter shaft stretched' aa, 'catheter shaft broken/fractured during use' and aa, 'catheter shaft damaged', listed in the grid below can 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
Analysis of the returned subject device found the catheter shaft was broken/fractured during use.There were no clinical consequences to the patient reported as a result of this event.

• Brand Name: AXS CATALYST 5 .058IN ID X 132CM - US
• Common Device Name: CATHETER, PERCUTANEOUS
• Manufacturer (Section D): STRYKER NEUROVASCULAR CORK; ida industrial estate; model farm road; cork NA ; EI NA
• Manufacturer (Section G): STRYKER NEUROVASCULAR CORK; ida industrial estate; model farm road; cork NA ; EI NA
• Manufacturer Contact: tara lopez ; 47900 bayside parkway; fremont, CA 94538 ; 5104132500
• MDR Report Key: 12973406
• Report Number: 3008881809-2021-00518
• Device Sequence Number: 17305045
• Product Code: DQY
• UDI-Device Identifier: 07613327011999
• UDI-Public: 07613327011999
• Combination Product (Y/N): N
• Initial Reporter State: NY
• Initial Reporter Country: US
• PMA/510(K) Number: K151667
• 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
• Report Date (Section B): 12/09/2021

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: 11/04/2022
• Device Model Number: M003IC0581320
• Device Catalogue Number: M003IC0581320
• Device Lot Number: 22563040
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/20/2021
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 12/01/2021
• Initial Report FDA Received Date: 12/09/2021
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/05/2020
• 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: LONG SHEATH (STRYKER MANUFACTURER); SYNCHRO WIRE (STRYKER MANUFACTURER)
• Patient Sex: Unknown