MAUDE Adverse Event Report: PENUMBRA, INC. POD12; HCG, KRD

Catalog Number RBYPOD12

Device Problems Inadequacy of Device Shape and/or Size (1583); Material Deformation (2976)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 10/04/2018

Event Type  malfunction  

Manufacturer Narrative

The device has been returned and the investigation results are pending.A follow up mdr will be submitted upon completion of the device investigation.This report is associated with mfr report numbers: 3005168196-2018-02180; 3005168196-2018-02181; 3005168196-2018-02182; 3005168196-2018-02183.

Event Description

The patient was undergoing a coil embolization procedure in the splenic artery using a pod12, pod packing coils (podjs) and ruby coils.It was noted that the patient¿s anatomy was tortuous.During the procedure, while attempting to deploy a pod12 into the target vessel using a lantern delivery microcatheter (lantern), the physician determined that the pod12 was oversized and therefore, it was removed.The pod12 pusher assembly then became kinked when the hospital technologist submerged it into saline to flush it.The physician then decided to remove the lantern.Next, the physician implanted a pod10 in the target vessel using a non-penumbra microcatheter.While advancing a podj through the microcatheter, the physician experienced resistance and the pusher assembly of the podj became kinked on the back end of the microcatheter; therefore, it was removed.The physician then implanted another podj in the target vessel with no issues.While advancing a ruby coil through the microcatheter, the physician experienced resistance and subsequently, the ruby coil unintentionally detached, with some of the ruby coil in the patient'' body.Therefore, the physician used manual aspiration to pull the detached coil inside the microcatheter and removed the microcatheter and coil together.The ruby coil was then removed and the microcatheter reinserted into the patient¿s body.After that, the physician successfully placed another ruby coil in the target vessel.While advancing a podj through the microcatheter, resistance was encountered and the podj pusher assembly became kinked; therefore, it was removed.The physician then placed another podj in the target vessel with no issues.While advancing another podj through the microcatheter, resistance was also encountered and the podj pusher assembly became kinked; therefore, it was removed.The procedure was completed using a new podj.It should be noted that a third microcatheter was used, but it is unknown at what point in the procedure.There was no alleged deficiency against the lantern; the physician preferred to use another microcatheter.There was no report of an adverse effect to the patient.

Manufacturer Narrative

Results: the pet lock was intact on the proximal end of the pusher assembly.The pusher assembly was kinked approximately 53.0 and 67.0 cm from the proximal end.The embolization coil was undamaged and was intact with the pusher assembly distal detachment tip (ddt).The coil was approximately 60.0 cm in length.Conclusions: evaluation of the returned pod12 confirmed a kinked device.The complaint reported that the pod12 was kinked when submerging the device into saline after retracting it outside the patient.If the device is forcefully mishandled outside of the patient, damage such as a kink may occur.During functional testing, the pod12 was able to advance and retract through its introducer sheath and a demo lantern without issue.Evaluation of the podj confirmed a kinked device.The complaint reported that resistance was experienced when advancing the podj through a non-penumbra microcatheter.If the device is forcefully advanced against resistance, damage such as a kink may occur.Based on the reported complaint, some of the kinks are likely incidental to the complaint and may have occurred post procedure.During functional testing, the device was able to be advanced through its introducer sheath and a demonstration lantern with resistance due to the pusher assembly kinks.The non-penumbra microcatheter was not returned for evaluation; therefore, the root cause of the initial resistance was unable to be determined.Evaluation of the ruby coil confirmed the embolization coil was missing from the pusher assembly.The proximal constraint sphere was present within the ddt.There was not a stretch resistant component visible in the constraint sphere, therefore, the root cause of the coil becoming detached could not be determined.The embolization coil was not returned for evaluation; therefore, the device was unable to be functionally tested.Evaluation of the podj was unable to confirm the reported kinks.Further evaluation revealed a detached embolization coil and the ddt was sheared off the distal end of the pusher assembly.If the ddt becomes sheared off the pusher assembly, it will likely cause the embolization coil to become detached.Based on the reported complaint, the sheared ddt and detached embolization coil were likely incidental.Evaluation of the podj confirmed a kinked device.If the device is forcefully advanced against resistance, the pusher assembly may become kinked.The non-penumbra microcatheter was not returned for evaluation; therefore, the root cause of the resistance was unable to be determined.Further evaluation revealed additional kinks and a detached embolization coil.Based on the reported complaint and return condition, these damages were likely incidental to the complaint.No other devices identified in the complaint were returned for evaluation.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.This report is associated with mfr report numbers: 1.3005168196-2018-02180, 2.3005168196-2018-02181, 3.3005168196-2018-02182, and 4.3005168196-2018-02183.

• Brand Name: POD12
• Type of Device: HCG, KRD
• Manufacturer (Section D): PENUMBRA, INC.; one penumbra place; alameda CA 94502
• MDR Report Key: 8028915
• MDR Text Key: 125908560
• Report Number: 3005168196-2018-02179
• Device Sequence Number: 1
• Product Code: HCG
• UDI-Device Identifier: 00814548019666
• UDI-Public: 00814548019666
• Combination Product (y/n): Y
• PMA/PMN Number: K173614
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup
• Report Date: 01/01/2005,10/04/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/01/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: RBYPOD12
• Device Lot Number: F83904
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/10/2018
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 01/01/2005
• Date Report to Manufacturer: 01/10/2005
• Date Manufacturer Received: 06/06/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 63 YR