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

Catalog Number PXSLIMSTR-A

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Neurological Deficit/Dysfunction (1982)

Event Date 02/20/2014

Event Type  Injury  

Manufacturer Narrative

From the information provided, there is no indication that there was any device malfunction, nonconformance, or misuse that contributed to the reported event.Neurological deficits including stroke are known and anticipated complications with these types of procedures and are noted in the device labeling.Therefore, it was determined that the reported right posterior limbic stroke was an anticipated procedural complication.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 numbers: 3005168196-2015-01315, 3005168196-2015-01316, 3005168196-2015-01317, 3005168196-2015-01318, 3005168196-2015-01319, 3005168196-2015-01320.Hospital did not return the device.

Event Description

The patient was undergoing a coil embolization in the right posterior internal carotid artery (ica) using penumbra coil 400 coils (pc400 coils) and a px slim delivery microcatheter (px slim).During the procedure, the physician deployed and detached six pc400 coils into the aneurysm with no immediate complications using the px slim.The following day, the patient experienced a severe right posterior limbic stroke.The event remained unresolved and no actions were taken.The reported right posterior limbic stroke was adjudicated to have an uncertain relationship to the pc400 coils and a possible relationship to the px slim, angiographic procedure and the aneurysm state.

• Brand Name: PX SLIM DELIVERY MICROCATHETER
• Type of Device: DQY
• Manufacturer (Section D): PENUMBRA, INC.; one penumbra place; alameda CA 94502
• Manufacturer (Section G): PENUMBRA, INC.; one penumbra place; alameda CA 94502
• Manufacturer Contact: kathleen kidd ; one penumbra place; alameda, CA 94502 ; 5107483200
• MDR Report Key: 5317017
• MDR Text Key: 34071330
• Report Number: 3005168196-2015-01321
• Device Sequence Number: 1
• Product Code: DQY
• UDI-Device Identifier: 00814548016436
• UDI-Public: 00814548016436
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K100826
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 11/24/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/21/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Physician
• Device Expiration Date: 07/31/2016
• Device Catalogue Number: PXSLIMSTR-A
• Device Lot Number: F36618
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 11/24/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/11/2013
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 46 YR