MAUDE Adverse Event Report: STRYKER NEUROVASCULAR CORK AXS CATALYST 6 - 060X132 (FDA); CATHETER, PERCUTEANEOUS

Catalog Number	M003IC0601320
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	04/18/2018
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during preparation, the subject catheter was broken in half when removed from the sheath.No patient consequences reported.
Event or Problem Description
It was reported that during preparation, the subject catheter was broken in half when removed from the sheath.No patient consequences reported.
Additional Manufacturer Narrative
The device history record (dhr) review confirms that the device met all material, assembly and performance specifications.Visual inspection was performed, and the distal access catheter shaft was found broken at 47.5 cm from the distal end confirming the reported complaint.Functional testing was not performed as the reported issue was confirmed with visual inspection.In conclusion, based on the information available, it is probable that the device was damaged when removing the distal access catheter from its packaging; therefore, an assignable cause of handling damage was assigned to the as reported and as analyzed issue 'nv ¿ dac shaft broken'.Expiration date: added.Gtin: added.Device evaluated by mfg: updated.Summary attached: updated.Manufacturing date: added.

• Brand Name: AXS CATALYST 6 - 060X132 (FDA)
• Common Device Name: CATHETER, PERCUTEANEOUS
• Manufacturer (Section D): STRYKER NEUROVASCULAR CORK; ida industrial estate; model farm road; cork NA
• MDR Report Key: 7531064
• Report Number: 3008881809-2018-00236
• Device Sequence Number: 10807038
• Product Code: DQY
• UDI-Device Identifier: 07613327012033
• UDI-Public: (01)07613327012033(17)190228(10)19629679
• Combination Product (Y/N): N
• Initial Reporter State: KY
• 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,Followup
• Report Date (Section B): 07/30/2018

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: 02/28/2019
• Device Catalogue Number: M003IC0601320
• Device Lot Number: 19629679
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/04/2018
• Initial Date Received by Manufacturer: 04/25/2018
• Supplement Date Received by Manufacturer: 07/05/2018
• Initial Report FDA Received Date: 05/21/2018
• Supplement Report FDA Received Date: 07/30/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1