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

Catalog Number	PXSLIM045-A
Medical Device Problem Code	Device Operational Issue (2914)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	12/17/2015
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
This device is available for return.A follow up mdr will be submitted upon completion of the device investigation.This report is associated with mfr report number: 3005168196-2016-00056.
Event or Problem Description
The patient was undergoing a coil embolization procedure using ruby coils and a px slim delivery microcatheter (px slim).During the procedure, the physician deployed and detached three ruby coils into the aneurysm using the px slim.While attempting to deliver a new ruby coil into the patient, the physician had difficulty advancing the ruby coil out of the px slim and decided to remove the coil.While the ruby coil was being removed, it unintentionally detached inside the px slim.The ruby coil was contained in the px slim and both were safely removed from the patient.The procedure was completed using a new px slim and another manufacturer's devices.There was no report of an adverse effect to the patient.
Additional Manufacturer Narrative
The ruby coil was detached from the pusher assembly.The stretch resistant (sr) wire of the coil was fractured, and the proximal constraint sphere was missing.The distal tip of the coil was stuck inside the px slim.Evaluation of the returned devices revealed that the coil sr wire was fractured.This type of damage typically occurs due to improper handling during use.If the ruby coil is forcefully retracted against resistance, this type of damage may occur.The root cause of the resistance mentioned in the complaint could not be determined.Penumbra coils and catheters are 100% visually inspected during in-process inspection.Penumbra coils are 100% functionally tested during in-process inspection.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 pma/510(k) was incorrectly reported on the initial mfr report and is being corrected on this follow-up # 2 mfr report.

• Brand Name: PX SLIM DELIVERY MICROCATHETER
• Common Device Name: DQY
• Manufacturer (Section D): PENUMBRA, INC.; one penumbra place; alameda CA 94502
• MDR Report Key: 5367296
• Report Number: 3005168196-2016-00057
• Device Sequence Number: 18891170
• Product Code: DQY
• UDI-Device Identifier: 00814548016405
• UDI-Public: 00814548016405
• Combination Product (Y/N): N
• Initial Reporter State: NC
• 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: Other
• Type of Report: Followup,Followup
• Report Date (Section B): 12/17/2015

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: 08/31/2018
• Device Catalogue Number: PXSLIM045-A
• Device Lot Number: F65496
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/20/2016
• Initial Date Received by Manufacturer: Not provided
• Supplement Date Received by Manufacturer: Not provided; 02/23/2016
• Initial Report FDA Received Date: 01/14/2016
• Supplement Report FDA Received Date: 03/07/2016; 09/13/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1