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

Catalog Number	PXSLIMSTR
Medical Device Problem Codes	Mechanical Problem (1384); Device Operates Differently Than Expected (2913)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	06/30/2017
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: 3005168196-2017-01465.
Event or Problem Description
The patient was undergoing a coil embolization procedure in the gastric artery using ruby coils.During the procedure, while attempting to advance a ruby coil through a px slim delivery microcatheter (px slim), the physician experienced resistance; therefore, the px slim and ruby coil were removed.The procedure was completed using a new ruby coil and another px slim.It addition, there was no noted damage to the px slim after removal.There was no report of an adverse effect to the patient.
Additional Manufacturer Narrative
The px slim delivery microcatheter (px slim) was kinked approximately 2.5 cm from the hub.Evaluation of the returned devices revealed that the ruby coil¿s embolization coil windings were offset and the pusher assembly was kinked in multiple locations.The offset coil winding likely occurred due to forceful advancement against resistance.If the device is continuously advanced against resistance, damage such as a kinked pusher assembly may occur.The od of the embolization coil was measured and found to be within specification.Evaluation of the returned px slim revealed that the microcatheter was kinked.This type damage likely occurred due to improper handling during use.If the device is manipulated with force during use, damage such as a kink may occur.The kink in the px slim likely contributed to the resistance experienced by the physician during advancement.The returned ruby coil could not be advanced past the kinked located on the returned px slim.The returned ruby coil could be advanced through a demonstration px slim with some resistance.A demonstration ruby coil could not be advanced pass the kink in the returned px slim.Penumbra coils and 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.This report is associated with mfr report number: 3005168196-2017-01465.

• Brand Name: PX SLIM DELIVERY MICROCATHETER
• Common Device Name: DQY
• Manufacturer (Section D): PENUMBRA, INC.; one penumbra place; alameda CA 94502
• MDR Report Key: 6835965
• Report Number: 3005168196-2017-01466
• Device Sequence Number: 1522024
• Product Code: DQY
• UDI-Device Identifier: 00814548016436
• UDI-Public: 00814548016436
• Combination Product (Y/N): N
• Initial Reporter Country: BR
• 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: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 08/10/2017

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: 01/06/2020
• Device Catalogue Number: PXSLIMSTR
• Device Lot Number: F73551
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/31/2017
• Initial Date Received by Manufacturer: 08/10/2017
• Supplement Date Received by Manufacturer: 09/08/2017
• Initial Report FDA Received Date: 08/31/2017
• Supplement Report FDA Received Date: 10/03/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 50 YR