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

Catalog Number	PXSLIMSTR
Medical Device Problem Codes	Fracture (1260); Physical Resistance/Sticking (4012)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	10/15/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Results: the px slim was fractured approximately 33.0 and 34.0 cm from the hub.Conclusion: evaluation of the two returned px slims revealed proximal fractures on both devices.These fractures were likely the reported distal fractures.If the device is forcefully manipulated against resistance, damage such as kinks may occur.Further manipulation of a kinked device may result in a fracture.No other devices associated with the complaint were returned for evaluation; therefore, the root cause of the resistance could not be determined.Penumbra catheters are inspected during in-process inspection and during quality inspection after manufacturing.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: 3005168196-2019-02088.
Event or Problem Description
The patient was undergoing a coil embolization procedure using a px slim delivery microcatheter (px slim).During the procedure, the physician experienced resistance while advancing the px slim into the target vessel.After placing a penumbra coil 400 (pc400) in the target vessel, the physician removed the px slim.While retracting, the physician experienced resistance and the px slim distal was found to be fractured upon removal.Next, the physician placed a new px slim but, reported the same resistance issued occurred while advancing.After placing another pc400, the px slim was removed; however, while retracting the same resistance occurred and the px slim distal tip was found to be fractured again upon removal.The procedure was completed using a new px slim.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: 9307013
• Report Number: 3005168196-2019-02089
• Device Sequence Number: 16687373
• Product Code: DQY
• UDI-Device Identifier: 00814548016443
• UDI-Public: 00814548016443
• Combination Product (Y/N): Y
• Initial Reporter State: NJ
• Initial Reporter Country: US
• PMA/510(K) Number: K100826
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 10/15/2019
• Report Date (Section F): 01/01/2005

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: 09/27/2021
• Device Catalogue Number: PXSLIMSTR
• Device Lot Number: F86137
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/16/2019
• Was the Report Sent to FDA?: Yes
• Date Report to Manufacturer: 01/10/2005
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/15/2019
• Initial Report FDA Received Date: 11/11/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 65 YR
• Date Report Sent to FDA: 01/01/2005