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

Catalog Number PXSLIMSTR

Device Problems Mechanical Problem (1384); Device Operates Differently Than Expected (2913)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 08/30/2017

Event Type  malfunction  

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: 3005168196-2017-01657.The hospital discarded the device.

Event Description

The patient was undergoing a coil embolization procedure in the left internal iliac artery (iia) using penumbra coil 400's (pc400's) and a px slim delivery microcatheter (px slim).During the procedure, the physician successfully placed two non-penumbra coils using the px slim.The physician then felt resistance advancing a pc400 through the px slim, and the pc400 became stuck.The physician attempted to forcefully retract the pc400; consequently, the pc400 coil broke.The physician therefore removed the px slim with the pc400 inside.The procedure was then completed using a new microcatheter and a new pc400.There was no report of an adverse effect to the patient.

Manufacturer Narrative

Please note that the following sections was inadvertently missed on the initial mfr report and is being included on this follow-up #01 mfr report: expiration date.Please note that the following section was incorrectly reported on the initial mfr report and is being corrected on this follow-up #01 mfr report: catalog #.This report is associated with mfr report number: 3005168196-2017-01657.

• Brand Name: PX SLIM DELIVERY MICROCATHETER
• Type of Device: DQY
• Manufacturer (Section D): PENUMBRA, INC.; one penumbra place; alameda CA 94502
• MDR Report Key: 6895416
• MDR Text Key: 89473230
• Report Number: 3005168196-2017-01658
• Device Sequence Number: 1
• Product Code: DQY
• UDI-Device Identifier: 00814548016443
• UDI-Public: 00814548016443
• Combination Product (y/n): Y
• PMA/PMN Number: K100826
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,foreign,health pr
• Type of Report: Initial,Followup
• Report Date: 01/01/2005,09/03/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/26/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Physician
• Device Expiration Date: 11/02/2019
• Device Catalogue Number: PXSLIMSTR
• Device Lot Number: F72612
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 01/01/2005
• Date Report to Manufacturer: 01/10/2005
• Date Manufacturer Received: 01/14/2005
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 64 YR