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

Catalog Number RBYPOD8

Device Problems Detachment Of Device Component (1104); Kinked (1339); Physical Resistance (2578)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 05/10/2018

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: 3005168196-2018-01139.The hospital discarded the device.

Event Description

The patient was undergoing a coil embolization procedure using in the left lingular pulmonary artery using a pod8.It was noted that the patient's anatomy was tortuous.During the procedure, while advancing a pod8 through a lantern delivery microcatheter (lantern), the physician experienced resistance and subsequently, the pod8 pusher assembly became kinked.Therefore, the physician slowly pulled the pod8 pusher assembly out of the lantern, but the pod8 had unintentionally detached and did not come out.It was reported that there was no resistance while retracting the pod8 pusher assembly suggesting that coil was already detached.A small portion of the pod8 was already advanced out of the lantern; therefore, the physician attached a syringe to the back of the lantern to create negative pressure on the lantern, and pulled the lantern and pod8 out together.The pod8 then came out of the lantern and into the 5f glide catheter when the lantern was pulled out.The physician then put negative pressure on the glide catheter using a syringe, and pulled the glide catheter and pod8 out through the 7f non-penumbra sheath.The procedure was completed using additional ruby coils and a new lantern, as access took significant time to regain and the physician did not want to take chance if blood congealed in the initial lantern.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: veronica farris ; one penumbra place; alameda, CA 94502 ; 5107483200
• MDR Report Key: 7584460
• MDR Text Key: 110584684
• Report Number: 3005168196-2018-01138
• Device Sequence Number: 1
• Product Code: HCG
• UDI-Device Identifier: 00814548013831
• UDI-Public: 00814548013831
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K141134
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 05/10/2018

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: Physician
• Device Catalogue Number: RBYPOD8
• Device Lot Number: F75157
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 05/10/2018
• Initial Date FDA Received: 06/08/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/24/2017
• 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: 70 YR