MAUDE Adverse Event Report: PENUMBRA, INC. POD8; HCG, KRD

Catalog Number RBYPOD8

Device Problems Difficult To Position (1467); Failure to Advance (2524); Mechanical Jam (2983)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 06/08/2016

Event Type  malfunction  

Manufacturer Narrative

Results: the pet lock was intact on the proximal end of the pod8 coil pusher assembly; the pusher assembly was kinked approximately 13.0 cm from the proximal end; the embolization coil was intact with the pusher assembly.Coagulated blood was observed inside the introducer sheath.Conclusions: evaluation of the returned device revealed that once the introducer sheath was flushed to clear the coagulated blood, the embolization coil was able to be advanced out of and retracted into the introducer sheath without issue.The coagulated blood inside the introducer sheath likely contributed to the embolization coil not being able to advance out of its introducer sheath during the procedure.Further evaluation revealed that the pod8 coil pusher assembly was kinked.This type of damage likely occurred due to forceful advancement against resistance during the attempt to re-insert coil into the px slim.The px slim mentioned in the complaint was not returned to penumbra for an evaluation.Pod8 coils are 100% functionally tested during in-process inspection.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 using pod8 coils.During the procedure, the physician deployed a pod8 coil into the target vessel but the coil lost its placement due to high flow of the vessel.Therefore, the pod8 coil was resheathed back into its introducer sheath and then removed from the patient.The physician then repositioned the px slim delivery microcatheter (px slim) and attempted to reintroduce the same pod8 coil.However, the physician encountered resistance and was unable to advance the coil out of its introducer sheath.Therefore, the procedure was completed using a new pod8 coil and a new px slim.It should be noted that there was no deficiency with the first px slim.A new px slim was opened due to the physician's preference for another tip.There was no report of an adverse effect to the patient.

• Brand Name: POD8
• Type of Device: HCG, KRD
• Manufacturer (Section D): PENUMBRA, INC.; one penumbra place; alameda CA 94502
• Manufacturer Contact: kathleen kidd ; one penumbra place; alameda, CA 94502 ; 5107483200
• MDR Report Key: 5780036
• MDR Text Key: 49126958
• Report Number: 3005168196-2016-00951
• Device Sequence Number: 1
• Product Code: HCG
• UDI-Device Identifier: 00814548013831
• UDI-Public: 00814548013831
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: K141134
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 06/08/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/08/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Physician
• Device Expiration Date: 09/30/2022
• Device Catalogue Number: RBYPOD8
• Device Lot Number: F60796
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/27/2016
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 06/08/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/25/2014
• 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: 16 YR
• Patient Weight: 55