MAUDE Adverse Event Report: STRYKER NEUROVASCULAR CORK EXCELSIOR XT-17 STD STRAIGHT 150CM; CATHETER, PERCUTANEOUS

Model Number	M003C1775ST0
Medical Device Problem Codes	Flaked (1246); Peeled/Delaminated (1454)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/08/2020
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the coating of the distal shaft of the microcatheter (subject device) was peeling away when removed from the dispenser hoop.The physician replaced it with a new device and continued the procedure without clinical consequences to the patient.
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 proximal shaft was bent and the distal shaft was flattened.The catheter tip and the hub were intact.There was a plastic material stuck to the proximal shaft 2cm from the hub.There was slight coating damage on the proximal shaft but there was no coating damage to the distal shaft.During functional inspection, the coating check was carried out and the coating was felt in the correct location.The reported complaint was not confirmed based on 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.There were small flakes of coating identified on the catheter proximal shaft and this may have been perceived as coating peeling by the physician.Additional information provided by the customer indicated that there were no anomalies noted to the device after removal from packaging and the dispenser hoop was flushed before removing the catheter.Therefore the as reported hydrophilic peeling issue cannot be confirmed and will be assigned a cause of not confirmed as the coating was not found to be peeling during analysis.The as analyzed catheter hydrophilic coating issue , catheter shaft flat/crushed and catheter shaft kinked/bent will be assigned handling damage as this complaint appears to be associated with handling of the product or portion of the product, during the procedure / upon removal of the product from the packaging / preparation of the product prior to use, a probable cause of handling damage was assigned.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 coating of the distal shaft of the microcatheter (subject device) was peeling away when removed from the dispenser hoop.The physician replaced it with a new device and continued the procedure without clinical consequences to the patient.Update: the product investigation confirmed that the hydrophilic peeling issue of the subject catheter was not confirmed based on analysis.There were small flakes of coating identified on the catheter proximal shaft which may have been perceived as coating peeling by the physician.It is highly unlikely that the small flakes of coating may contributed to and/or cause any patient injury; therefore, this record has been deemed non-reportable.

• Brand Name: EXCELSIOR XT-17 STD STRAIGHT 150CM
• Common Device Name: CATHETER, PERCUTANEOUS
• Manufacturer (Section D): STRYKER NEUROVASCULAR CORK; ida industrial estate; model farm road; cork NA ; EI NA
• MDR Report Key: 10610724
• Report Number: 3008881809-2020-00280
• Device Sequence Number: 1152234
• Product Code: DQY
• UDI-Device Identifier: 07613252714866
• UDI-Public: 07613252714866
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K142565
• 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): 11/17/2020

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: 03/08/2022
• Device Model Number: M003C1775ST0
• Device Catalogue Number: M003C1775ST0
• Device Lot Number: 22178608
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/25/2020
• Initial Date Received by Manufacturer: 09/10/2020
• Supplement Date Received by Manufacturer: 10/30/2020
• Initial Report FDA Received Date: 09/30/2020
• Supplement Report FDA Received Date: 11/17/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1