MAUDE Adverse Event Report: PENUMBRA, INC. POD PACKING COIL; HCG, KRD

Catalog Number RBYPODJ60

Device Problems Detachment Of Device Component (1104); Mechanical Jam (2983)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 12/29/2017

Event Type  malfunction  

Manufacturer Narrative

The product was not returned for evaluation.Without the return of the device, the root cause of the problem cannot be determined.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 number: 3005168196-2018-00217.

Event Description

The patient was undergoing a coil embolization procedure using pod packing coils (podjs).During the procedure, the physician successfully deployed and detached a podj using a lantern delivery microcatheter (lantern).The second podj then became stuck within the lantern while being advanced, and when the physician attempted to retract it, the podj unintentionally detached.The physician therefore removed the non-penumbra guide catheter with the lantern and podj inside from the patient.The procedure was then completed using a new lantern, a new catheter, and additional ruby coils.It was reported that the physician believes the lantern might have moved back in the guide catheter, causing the podj to become stuck.There was no report of an adverse effect to the patient.

• Brand Name: POD PACKING COIL
• Type of Device: HCG, KRD
• Manufacturer (Section D): PENUMBRA, INC.; one penumbra place; alameda CA 94502
• Manufacturer (Section G): PENUMBRA, INC.; one penumbra place; alameda CA 94502
• Manufacturer Contact: veronica farris ; one penumbra place; alameda, CA 94502 ; 5107483200
• MDR Report Key: 7219061
• MDR Text Key: 98423647
• Report Number: 3005168196-2018-00216
• Device Sequence Number: 1
• Product Code: HCG
• UDI-Device Identifier: 00814548017679
• UDI-Public: 00814548017679
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K170852
• 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: 12/29/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/25/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Physician
• Device Catalogue Number: RBYPODJ60
• Device Lot Number: F80012
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 12/29/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/16/2017
• 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: 33 YR