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

Catalog Number PXSLIMSTR

Device Problems Adverse Event Without Identified Device or Use Problem (2993); Device Handling Problem (3265)

Patient Problems No Patient Involvement (2645); No Known Impact Or Consequence To Patient (2692)

Event Date 08/17/2015

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 mdr is associated with mdr 3005168196-2015-00897, 00898, and 922.Device discarded by hospital.

Event Description

The patient was undergoing a coil embolization procedure using a px slim delivery microcatheter (px slim) and ruby coils.During the procedure, a px slim fell to the ground, rendering it unsterile and it was not used.The procedure continued using a new px slim.The physician met difficulty while advancing two ruby coils through the px slim and they both became kinked and were removed.The procedure successfully continued using a new microcatheter and additional ruby coils.There was no report of an adverse effect on the patient.

Manufacturer Narrative

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: 3005168196-2015-00899.Section h.Box 4.Device manufacture date.This report is associated with mfr report numbers: 3005168196-2015-00897; 3005168196-2015-00898; 3005168196-2015-00922.

• Brand Name: PX SLIM DELIVERY MICROCATHETER
• Type of Device: DQY
• Manufacturer (Section D): PENUMBRA, INC.; one penumbra place; alameda CA 94502
• MDR Report Key: 5082338
• MDR Text Key: 26007277
• Report Number: 3005168196-2015-00899
• Device Sequence Number: 1
• Product Code: DQY
• UDI-Device Identifier: 00814548016436
• UDI-Public: 00814548016436
• Combination Product (y/n): Y
• PMA/PMN Number: K100826
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Followup
• Report Date: 01/01/2005,08/17/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/16/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Physician
• Device Expiration Date: 04/30/2018
• Device Catalogue Number: PXSLIMSTR
• Device Lot Number: F63556
• 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