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

Catalog Number	PXSLIM045
Medical Device Problem Code	Device Operates Differently Than Expected (2913)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	09/13/2016
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Results: the px slim delivery microcatheter (px slim) was kinked approximately 2.5 and 46.5 cm from the hub; the px slim was ovalized in multiple locations from the distal tip to approximately 13.0 cm.Conclusions: evaluation of returned devices revealed that the pod4¿s embolization coil was detached from its pusher assembly.This type of damage typically occurs due to improper handling during use.If the device is forcefully retracted against resistance, the distal section of the pusher assembly may elongate, which may extend the distal detachment tip (ddt) beyond the reach of the pull wire, which would result in the embolization coil detaching from the pusher assembly.Further evaluation of the pod4 revealed that the pusher assembly was kinked in multiple locations.These kinks were likely incidental and may have occurred during packaging the device for return.Evaluation of the px slim revealed that the catheter¿s shaft was ovalized and kinked.These types of damages may have occurred when the physician attempted to retract the px slim to straighten it out after the px slim prolapsed on itself inside the vertebral artery, as was reported in the complaint.Further forceful manipulation of the px slim during repositioning may have contributed to the kinks observed along the catheter shaft.The damage noted on the px slim may have contributed to any resistance experienced by the physician while manipulating the pod4.The od of the embolization coil and proximal constraint sphere were measured and found to be within specification.The id of the ddt was measured and found to be within specification.All 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.This report is associated with mfr report number: 3005168196-2016-01453.
Event or Problem Description
The patient was undergoing a coil embolization procedure to sacrifice a branch of the vertebral artery using pod4 coils.During the procedure, the physician placed another manufacturer¿s diagnostic catheter in the target vessel before advancing a px slim delivery microcatheter (px slim) through it.The physician then successfully deployed and detached two penumbra coil 400's and a pod4 coil in the target vessel using the px slim.After, placing the pod4, the flow was shut but the physician wanted to place a fourth coil to insure total blockage.After, placing the pod4, the flow was shut but the physician wanted to place a fourth coil to insure total blockage.The physician then attempted to place another pod4 into the target vessel.It was reported that the px slim flipped into a loop inside the vertebral vessel and the physician attempted pulling it back to straighten it out.However, the px slim would not straighten until the diagnostic catheter was slid over it.At some point during the repositioning of the system, the pod4 unintentionally detached, with most of the coil still inside the px slim.The physician then wedged the pusher assembly alongside the pod4, the px slim, and the diagnostic catheter and withdrew the whole system.The physician did another angiogram and was satisfied with the result; therefore, another coil was not necessary and the procedure ended at this point.It should be noted that the physician maintained continuous flush through the rotating hemostasis valve (rhv).There was no report of an adverse effect to the patient.

• Brand Name: PX SLIM DELIVERY MICROCATHETER
• Common Device Name: DQY
• Manufacturer (Section D): PENUMBRA, INC.; one penumbra place; alameda CA 94502
• MDR Report Key: 6125360
• Report Number: 3005168196-2016-01698
• Device Sequence Number: 710131
• Product Code: DQY
• UDI-Device Identifier: 00814548016405
• UDI-Public: 00814548016405
• Combination Product (Y/N): N
• Initial Reporter State: NJ
• 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: Physician
• Type of Report: Initial
• Report Date (Section B): 09/13/2016

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: No Information
• Device Expiration Date: 10/31/2018
• Device Catalogue Number: PXSLIM045
• Device Lot Number: F66194
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/28/2016
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/13/2016
• Initial Report FDA Received Date: 11/23/2016
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 31 YR