MAUDE Adverse Event Report: PENUMBRA, INC. PX SLIM DELIVERY MICROCATHETER; DQY

Catalog Number	PXSLIM045-A
Medical Device Problem Codes	Kinked (1339); Device Handling Problem (3265)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	02/04/2016
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The product was not returned for evaluation.Without the return of the device, the root cause of the problem cannot be determined.The manufacturing records for this lot were reviewed and did not reveal any outstanding discrepancies, design, or quality concerns.This report is associated with mfr report number: 3005168196-2016-00591.The hospital discarded the device.
Event or Problem Description
The patient was undergoing a coil embolization procedure using a px slim delivery microcatheter (px slim) and ruby coils.During the procedure, upon inserting a px slim 90 degrees in the patient, the physician noticed that it was not the correct angle; therefore, it was exchanged for a px slim 45 degrees while advancing a ruby coil through the px slim 45 degrees, the px slim 45 degrees became kinked; this in turn caused the ruby coil to unintentionally detach within the px slim 45 degrees the px slim 45 degrees and detached ruby coil were removed from the patient and the procedure was completed using new ruby coils with a new px slim straight.There was no report of an adverse effect to the patient.

• Brand Name: PX SLIM DELIVERY MICROCATHETER
• Common Device Name: DQY
• Manufacturer (Section D): PENUMBRA, INC.; one penumbra place; alameda CA 94502
• MDR Report Key: 5613422
• Report Number: 3005168196-2016-00590
• Device Sequence Number: 10775445
• Product Code: DQY
• UDI-Device Identifier: 00814548016405
• UDI-Public: 00814548016405
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: K100826
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 02/04/2016

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: Physician
• Device Expiration Date: 09/30/2017
• Device Catalogue Number: PXSLIM045-A
• Device Lot Number: F46223
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/04/2016
• Initial Report FDA Received Date: 04/27/2016
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 24 YR