MAUDE Adverse Event Report: STRYKER NEUROVASCULAR CORK XT-17 STANDARD STRAIGHT; CATHETER, PERCUTANEOUS

Catalog Number	M003C1775ST0
Medical Device Problem Code	Peeled/Delaminated (1454)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	05/28/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The electronic device history record (edhr) review confirms that the device met all material, assembly and performance specifications.During visual inspection, a detached target coil was still inside the microcatheter shaft and the microcatheter shaft was found damaged near the distal tip.During functional testing, the detached coil was pushed out from the microcatheter using a mandrel.The microcatheter ptfe (polytetrafluoroethylene) inner lining came out from the distal tip of the catheter along with the coil.In case of this complaint, the detached target coil found inside the microcatheter possibly caused the peeling of the ptfe inner lining.This complaint appears to be associated with a product that met stryker and design and manufacturing specifications and was used in accordance with the direction for use (dfu), but performance was limited due to procedural factors during use; therefore, an assignable cause of procedural factors was assigned to the as analyzed issue catheter ptfe inner lining peeling.
Event or Problem Description
Analysis of the returned device found that the catheter ptfe (polytetrafluoroethylene) inner lining peeling.There were no clinical consequences to the patient reported as a result of this event.

• Brand Name: XT-17 STANDARD STRAIGHT
• Common Device Name: CATHETER, PERCUTANEOUS
• Manufacturer (Section D): STRYKER NEUROVASCULAR CORK; ida industrial estate; model farm road; cork NA
• MDR Report Key: 8889028
• Report Number: 3008881809-2019-00238
• Device Sequence Number: 2119718
• Product Code: DQY
• UDI-Device Identifier: 07613252714866
• UDI-Public: 07613252714866
• Combination Product (Y/N): N
• 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
• Report Date (Section B): 08/13/2019

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: 11/27/2020
• Device Catalogue Number: M003C1775ST0
• Device Lot Number: 21053687
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/04/2019
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 07/25/2019
• Initial Report FDA Received Date: 08/13/2019
• 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: TARGET COIL (STRYKER)
• Patient Age: 80