MAUDE Adverse Event Report: PENUMBRA, INC. POD10; HCG, KRD

Catalog Number RBYPOD10

Device Problems Deformation Due to Compressive Stress (2889); Physical Resistance/Sticking (4012)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 06/20/2018

Event Type  malfunction  

Manufacturer Narrative

This device is available for return.A follow up mdr will be submitted upon completion of the device investigation.

Event Description

The patient was undergoing a coil embolization procedure in the hypogastric artery using pod10s.During the procedure, while attempting to advance a pod10 through a lantern delivery microcatheter (lantern), the physician experienced resistance and the pod10 pusher assembly became kinked.Subsequently, the pod10 would not advance smoothly and therefore, was removed.The procedure was completed using another pod10 and the same lantern.There was no report of adverse effect to the patient.

Manufacturer Narrative

Results: the pod10 had bends at approximately 32.0 cm and 44.0 cm from the proximal end of the pusher.Kinks were found approximately 78.5 cm and 119.5 cm from the proximal end of the pusher.A fracture was found approximately 118.0 cm from the proximal end of the pusher.The embolization coil was detached from its pusher assembly inside the introducer sheath.The pod10 was fractured; therefore, functional analysis could not be performed.Conclusions: evaluation of the returned pod10 revealed kink, bend, and fracture damage along the length of the pusher assembly.These damages may have been a result of forcefully advancing the device against resistance.As reported in the complaint, some of the damage occurred outside the patient body post-procedure.The microcatheter identified in the complaint was not returned for evaluation; therefore, the root cause of the resistance experienced could not be determined.Further evaluation revealed the embolization coil was detached.If the pusher assembly becomes fractured it will likely allow the pull wire to retract from the distal detachment tip (ddt), detaching the embolization coil.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.

• Brand Name: POD10
• 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: 7700192
• MDR Text Key: 114409724
• Report Number: 3005168196-2018-01411
• Device Sequence Number: 1
• Product Code: HCG
• UDI-Device Identifier: 00814548019659
• UDI-Public: 00814548019659
• Combination Product (y/n): Y
• Reporter Country Code: US
• PMA/PMN Number: K173614
• 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,Followup
• Report Date: 01/01/2005,06/20/2018

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: Health Professional
• Device Catalogue Number: RBYPOD10
• Device Lot Number: F82203
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/19/2018
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 01/01/2005
• Date Report to Manufacturer: 01/10/2005
• Initial Date Manufacturer Received: 06/20/2018
• Initial Date FDA Received: 07/18/2018
• Supplement Dates Manufacturer Received: 10/19/2018
• Supplement Dates FDA Received: 10/25/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/06/2018
• 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