MAUDE Adverse Event Report: STRYKER NEUROVASCULAR CORK AXS CATALYST 5 - 058X132 (FDA); CATHETER, PERCUTANEOUS

Catalog Number	M003IC0581320
Medical Device Problem Code	Material Puncture/Hole (1504)
Health Effect - Clinical Code	No Patient Involvement (2645)
Date of Event	06/28/2018
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that prior to operation when opening the product, the catheter shaft had a hole.There was no patient involvement.
Additional Manufacturer Narrative
The device history record review confirms that the device met all material, assembly and performance specifications.Visual examination of the returned device revealed that the distal access catheter was broken at 47cm from the distal end.As per the additional information received, the issue was observed during/after opening the packaging.It is probable that the device was damaged as a result of handling of the device during removal of the device from its packaging, therefore an assignable cause of handling damage will be assigned to this investigation.Expiration date: updated.Device evaluated by mfg: updated.Summary attached: updated.Manufacturing date: updated.
Event or Problem Description
It was reported that prior to operation when opening the product, the catheter shaft had a hole.There was no patient involvement.

• Brand Name: AXS CATALYST 5 - 058X132 (FDA)
• Common Device Name: CATHETER, PERCUTANEOUS
• Manufacturer (Section D): STRYKER NEUROVASCULAR CORK; ida industrial estate; model farm road; cork NA
• MDR Report Key: 7724794
• Report Number: 3008881809-2018-00323
• Device Sequence Number: 1619171
• Product Code: DQY
• UDI-Device Identifier: 07613327011999
• UDI-Public: 07613327011999
• Combination Product (Y/N): N
• Initial Reporter State: FL
• 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: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 09/24/2018

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: 08/31/2019
• Device Catalogue Number: M003IC0581320
• Device Lot Number: 19950896
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/18/2018
• Initial Date Received by Manufacturer: 06/28/2018
• Supplement Date Received by Manufacturer: 08/27/2018
• Initial Report FDA Received Date: 07/26/2018
• Supplement Report FDA Received Date: 09/24/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1