MAUDE Adverse Event Report: STRYKER NEUROVASCULAR CORK AXS CATALYST 6 .060IN ID X 132CM - US; CATHETER, PERCUTANEOUS

Model Number	M003IC0601320
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	05/19/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Device is not available to manufacturer.
Event or Problem Description
It was reported that during the procedure of acute ischemic stroke case, the patient's blood vessel were so tortuous that it was difficult to enter a catheter to perform thrombectomy at mca.To penetrate the blocked blood vessel, the physician used competitor product twice but was not able to perform thrombectomy.Then the physician used a microcatheter (subject device) to treat cerebral infarction.During the procedure, the distal part of the subject microcatheter was cut off and the maker band on it was partially cut off.The cut off portion of the marker went to the blocked mca thrombus side of the patient's blood vessels.The physician could not retrieve the broken portion of the maker and finished the procedure.No further information is available.
Additional Manufacturer Narrative
Due to the automated mes system there are controls in the manufacturing process to ensure the product met specifications upon release.During visual inspection, the catheter was seen to be kinked bent from 112cm onwards and the catheter tip was seen to be broken/fractured.Functional inspection was not carried out due to condition of returned device.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 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.This can confirm the as reported and as well as the as analyzed 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 that during the procedure of acute ischemic stroke case, the patient's blood vessel were so tortuous that it was difficult to enter a catheter to perform thrombectomy at mca.To penetrate the blocked blood vessel, the physician used competitor product twice but was not able to perform thrombectomy.Then the physician used a microcatheter (subject device) to treat cerebral infarction.During the procedure, the distal part of the subject microcatheter was cut off and the maker band on it was partially cut off.The cut off portion of the marker went to the blocked mca thrombus side of the patient's blood vessels.The physician could not retrieve the broken portion of the maker and finished the procedure.No further information is available.

• Brand Name: AXS CATALYST 6 .060IN 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
• MDR Report Key: 11992092
• Report Number: 3008881809-2021-00248
• Device Sequence Number: 3215627
• Product Code: DQY
• UDI-Device Identifier: 07613327012033
• UDI-Public: 07613327012033
• Combination Product (Y/N): N
• Initial Reporter Country: KS
• PMA/510(K) Number: K183463
• 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): 08/23/2021

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: 08/03/2022
• Device Model Number: M003IC0601320
• Device Catalogue Number: M003IC0601320
• Device Lot Number: 22359261
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/23/2021
• Initial Date Received by Manufacturer: 05/20/2021
• Supplement Date Received by Manufacturer: 07/28/2021
• Initial Report FDA Received Date: 06/14/2021
• Supplement Report FDA Received Date: 08/23/2021
• 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: UNKNOWN CATHETERS; UNKNOWN CATHETERS
• Outcome Attributed to Adverse Event: Other