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

Catalog Number	PXSLIM090
Medical Device Problem Codes	Physical Resistance (2578); Device Operates Differently Than Expected (2913)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	07/03/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device has been returned and the investigation results are pending.A follow up mdr will be submitted upon completion of the device investigation.
Event or Problem Description
The patient was undergoing a coil embolization procedure in the right internal iliac artery (iia) using a px slim delivery microcatheter (px slim).During the procedure, the physician advanced the px slim towards the target vessel and then attempted to advance an initial pod4 through the px slim.While advancing the pod4 approximately ten centimeters into the px slim, the physician encountered resistance and retracted the coil.The px slim was then flushed and another attempt was made to advance the same pod4 through the px slim; however, resistance was met again and the physician removed the px slim containing the pod4.The procedure was then successfully completed using a new px slim, the same pod4 and an additional penumbra coil.There was no report of an adverse effect to the patient.
Additional Manufacturer Narrative
The px slim delivery microcatheter (px slim) was very slightly bent at approximately 10.0 cm from the proximal hub.Evaluation of the returned px slim revealed a very slight bend on its proximal region.This damage was likely incidental and may have occurred during packaging for return to penumbra.A mandrel and demonstration coil were both advanced through the px slim lumen and out the distal tip without issue or resistance.The px slim functioned within penumbra specification and no issue was found.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.
Additional Manufacturer Narrative
Please note that the following section were incorrectly reported on the initial mfr report and are being corrected on this follow-up #02 mfr report: 1.Date of this report.2.Date received by manufacturer.

• Brand Name: PX SLIM DELIVERY MICROCATHETER
• Common Device Name: DQY
• Manufacturer (Section D): PENUMBRA, INC.; one penumbra place; alameda CA 94502
• MDR Report Key: 6760322
• Report Number: 3005168196-2017-01278
• Device Sequence Number: 16529238
• Product Code: DQY
• UDI-Device Identifier: 00814548012520
• UDI-Public: 00814548012520
• Combination Product (Y/N): Y
• Initial Reporter Country: JA
• PMA/510(K) Number: K100826
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: distributor,foreign,health pr
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 07/04/2017
• 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: Physician
• Device Expiration Date: 10/31/2017
• Device Catalogue Number: PXSLIM090
• Device Lot Number: F46460
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/31/2017
• Was the Report Sent to FDA?: Yes
• Date Report to Manufacturer: 01/10/2005
• Initial Date Received by Manufacturer: 07/03/2017
• Supplement Date Received by Manufacturer: 08/04/2017; 07/04/2017
• Initial Report FDA Received Date: 08/02/2017
• Supplement Report FDA Received Date: 09/03/2017; 05/24/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 76 YR
• Patient Weight: 80
• Date Report Sent to FDA: 01/01/2005