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

Catalog Number RBYPOD4

Device Problems Detachment Of Device Component (1104); Difficult To Position (1467); Retraction Problem (1536)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 06/10/2016

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 gastroduodenal artery (gda) using pod4 coils.During the procedure, the physician advanced a pod4 coil into the gda using a px slim delivery microcatheter (px slim).After making two attempts to deploy the pod4 coil, the physician retracted the coil in order to redeploy it.However, the pod4 coil was unable to retract and then unintentionally detached within the px slim.The physician did not encounter any resistance while retracting the coil.Subsequently, the px slim containing the detached pod4 coil was removed from the patient and then the detached coil was aspirated out using a syringe.Thereafter, the procedure was completed using a new pod4 coil and the same px slim.It should be noted that the physician did not use a rotating hemostasis valve (rhv) during the procedure but did have a continuous flush through the px slim.There was no report of an adverse effect to the patient.

Manufacturer Narrative

Result: the pet lock was broken on the proximal end of the pod6 pusher assembly.The pusher assembly was kinked throughout its length.The embolization coil was detached from the pusher assembly, had the proximal constraint sphere intact, and was covered in a foreign substance.Conclusion: evaluation of the returned devices revealed the pet lock was broken on the pod6 pusher assembly and the embolization coil was detached.A broken pet lock indicates that a pull force was applied to the proximal end of the pull wire.If a pull force is applied to the proximal end of the pull wire and the pet lock becomes broken, the embolization coil will, by design, detach.Further evaluation revealed the pod6 pusher assembly was kinked throughout its length.This damage was likely incidental and may have occurred during packaging the device for return.Since the pet lock was broken and the pusher assembly was severely damaged throughout its length, the root cause of the unintentional detachment could not be determined.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.

• Brand Name: POD4
• 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: 5799792
• MDR Text Key: 49746651
• Report Number: 3005168196-2016-00996
• Device Sequence Number: 1
• Product Code: HCG
• UDI-Device Identifier: 00814548013756
• UDI-Public: 00814548013756
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K141134
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,foreign,health pr
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 06/16/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/15/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Physician
• Device Expiration Date: 02/29/2024
• Device Catalogue Number: RBYPOD4
• Device Lot Number: F67966
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/19/2016
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/05/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/18/2016
• 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: 79 YR