MAUDE Adverse Event Report: PENUMBRA, INC. POD4; HCG, KRD

Catalog Number RBYPOD4

Device Problems Bent (1059); Failure to Advance (2524)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 02/02/2017

Event Type  malfunction  

Manufacturer Narrative

Results: the pod4 pusher assembly was bent in multiple locations throughout its length and kinked approximately 75.0 and 81.0 cm from the proximal end.The embolization coil was intact with the pusher assembly.Conclusions: evaluation of the returned device confirmed the pusher assembly was kinked.This damage may have occurred due to forceful manipulation of the pod4 during advancement into a microcatheter.Further evaluation revealed the pusher assembly was bent in multiple locations.This damage was likely incidental and may have occurred during packaging the device for return to penumbra.Penumbra coils 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.

Event Description

The patient was undergoing a coil embolization procedure in the right internal iliac artery using pod4.During the procedure, the physician advanced a pod4 in the patient using a non-penumbra microcatheter; however,the physician decided to resheath and retract the pod4 in order to reposition the microcatheter further in the vessel.Upon attempting to advance the pod4 through the microcatheter again, the physician noticed that the pod4 hypotube became bent and consequently the pod4 was unable to advance any further in the microcatheter.Again, the pusher wire assembly became kinked.The physician therefore removed the pod4 and completed the procedure using the same non-penumbra microcatheter and a new pod4.In addition, it was reported that the physician did not use a rotating hemostasis valve, and flushed the microcatheter routinely between detachment and contrast injections.There was no report of an adverse effect to the patient.

• Brand Name: POD4
• Type of Device: HCG, KRD
• Manufacturer (Section D): PENUMBRA, INC.; one penumbra place; alameda CA 94502
• Manufacturer Contact: veronica farris ; one penumbra place; alameda, CA 94502 ; 5107483200
• MDR Report Key: 6373247
• MDR Text Key: 68975307
• Report Number: 3005168196-2017-00287
• Device Sequence Number: 1
• Product Code: HCG
• UDI-Device Identifier: 00814548013756
• UDI-Public: 00814548013756
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K141134
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 02/02/2017

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
• Device Operator: Physician
• Device Catalogue Number: RBYPOD4
• Device Lot Number: F69992
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/08/2017
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 02/02/2017
• Initial Date FDA Received: 03/02/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/07/2016
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Age: 83 YR