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

Catalog Number	PXSLIM045
Medical Device Problem Codes	Stretched (1601); Device Operates Differently Than Expected (2913); Difficult to Advance (2920)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	05/22/2017
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 in the vertebral artery using a px slim delivery microcatheter (px slim).It was noted that the anatomy was really difficult with the patient.During the procedure, after advancing a px slim to the treatment site using a neuron max, the px slim kicked out when the physician attempted to advance it into the aneurysm; therefore, the physician decided to retract the px slim for repositioning.Upon pulling the px slim out of the rotating hemostasis valve (rhv), the physician noticed that the px slim strain relief was stretched.Therefore, the px slim was removed and the procedure was completed using a new px slim and the same neuron max without further issues.There was no report of an adverse effect to the patient.
Additional Manufacturer Narrative
Results: the strain relief was stretched on the proximal end of the px slim.Conclusions: evaluation of the returned px slim confirmed that the strain relief was stretched.This type of damage typically occurs due to improper handling during use.If the device is forcefully retracted out of a rotating hemostasis valve (rhv) without first opening the valve, damage such as this may occur.Penumbra catheters are visually 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 sections were incorrectly reported on the initial mfr report and are being corrected on this follow-up #02 mfr report: 1.Report source.2.Device manufacture date.

• Brand Name: PX SLIM DELIVERY MICROCATHETER
• Common Device Name: DQY
• Manufacturer (Section D): PENUMBRA, INC.; one penumbra place; alameda CA 94502
• MDR Report Key: 6663880
• Report Number: 3005168196-2017-00987
• Device Sequence Number: 1972817
• Product Code: DQY
• UDI-Device Identifier: 00814548016405
• UDI-Public: 00814548016405
• Combination Product (Y/N): Y
• Initial Reporter Country: LO
• PMA/510(K) Number: K100826
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,distri
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 05/24/2017
• 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: 01/31/2019
• Device Catalogue Number: PXSLIM045
• Device Lot Number: F67662
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/22/2017
• Was the Report Sent to FDA?: Yes
• Date Report to Manufacturer: 01/10/2005
• Initial Date Received by Manufacturer: 05/24/2017
• Supplement Date Received by Manufacturer: 06/27/2017; 01/14/2005
• Initial Report FDA Received Date: 06/23/2017
• Supplement Report FDA Received Date: 07/27/2017; 04/10/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 72 YR
• Date Report Sent to FDA: 01/01/2005