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

Catalog Number	PXSLIM130
Medical Device Problem Codes	Occlusion Within Device (1423); Physical Resistance (2578)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	01/30/2017
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: 3005168196-2017-00270.
Event or Problem Description
The patient was undergoing a coil embolization procedure in the renal artery using penumbra coil 400''s (pc400¿s) and a px slim delivery microcatheter (px slim).During the procedure, the physician first placed another manufacturer¿s catheter into the target vessel and then advanced a px slim through it.While advancing a pc400 through the px slim, the physician experienced resistance around the tip of the px slim and subsequently, the pc400 became stuck.The physician then decided to retract the pc400; however, upon retraction, the pc400 unintentionally detached from the pusher assembly inside the px slim.Therefore, the px slim containing the detached coil was removed.With the devices outside of the patient's body, the physician attempted to push out the pc400 using a syringe but the coil did not come out of the px slim.Thereafter, the procedure was completed using additional coils and a new px slim.There was no report of an adverse effect to the patient.
Additional Manufacturer Narrative
The px slim delivery microcatheter (px slim) was kinked approximately 79.0 and 80.0 cm from the hub and had minor bends in the distal shaft.During functional analysis, a 0.025¿ mandrel was inserted into the px slim and advanced.Resistance was experienced when the mandrel reached the kinks located 79.0 and 80.0 cm from the hub.Evaluation of the returned devices revealed that the px slim was kinked.This damage may have occurred due to forceful manipulation of the px slim within patient anatomy.During functional analysis, resistance was experienced upon advancing a mandrel through the kinked region of the px slim.The kinks in the px slim likely contributed to the resistance experienced while advancing the pc400 during the procedure.Further evaluation revealed that the px slim had bends in its distal shaft.This damage was likely incidental and likely occurred due to placement within patient anatomy.The pc400 embolization coil was detached from the pusher assembly and compressed on its proximal end, and the out diameters (od's) of the proximal constraint sphere and embolization coil were within specification.Since the pusher assembly of the pc400 was not returned for evaluation, the root cause of the unintentional detachment could not be determined.The compression of the embolization coil likely occurred due to forceful advancement of the pc400 against resistance.The pc400 pusher assembly and the non-penumbra catheter mentioned in the complaint were not returned for evaluation.Penumbra coils and catheters are 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.

• Brand Name: PX SLIM DELIVERY MICROCATHETER
• Common Device Name: DQY
• Manufacturer (Section D): PENUMBRA, INC.; one penumbra place; alameda CA 94502
• MDR Report Key: 6370480
• Report Number: 3005168196-2017-00271
• Device Sequence Number: 11075593
• Product Code: DQY
• UDI-Device Identifier: 00814548012537
• UDI-Public: 00814548012537
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K100826
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: distributor,foreign,health pr
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 01/31/2017

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: 11/30/2018
• Device Catalogue Number: PXSLIM130
• Device Lot Number: F66420
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/08/2017
• Type of Report(Section G): FDA Requested
• Initial Date Received by Manufacturer: 01/31/2017
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 03/01/2017
• Supplement Report FDA Received Date: 05/03/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1