MAUDE Adverse Event Report: PENUMBRA, INC. POD5; HCG, KRD

Catalog Number RBYPOD5

Device Problems Device Damaged Prior to Use (2284); Device Fell (4014)

Patient Problem No Patient Involvement (2645)

Event Date 04/04/2019

Event Type  malfunction  

Manufacturer Narrative

The product was not returned for evaluation.The reported complaint involves the sterility of a dropped device prior to use in the patient.Sterility of a dropped device cannot be confirmed in the evaluation lab and does not involve manufacturing records; therefore, an investigation will not be performed.This report is associated with mfr report numbers: 3005168196-2019-00876; 3005168196-2019-00877; 3005168196-2019-00878; 3005168196-2019-00879.

Event Description

The patient was undergoing a coil embolization procedure in the mesenteric artery and the aorta using pod5s and ruby coils.During the procedure, the fellow accidentally dropped a pod5 on the floor while removing it from the packaging hoop.The pod5 was dropped prior to use and, therefore, it was not used in the procedure.The procedure was then continued using a new pod5.The physician successfully placed multiple ruby coils using a lantern delivery microcatheter (lantern).The fellow then accidentally kinked a ruby coil (f83494) while removing it from the packaging hoop.The physician still attempted to advance the ruby coil through the lantern, however, was unable to.Therefore, the ruby coil was removed, and a new ruby coil was successfully placed.Throughout the remainder of the procedure, three more ruby coils were inadvertently kinked upon removal from their packaging hoops and, therefore, not used in the procedure.The procedure was completed using other ruby coils.There was no report of an adverse effect to the patient.

• Brand Name: POD5
• 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: 8575022
• MDR Text Key: 143940736
• Report Number: 3005168196-2019-00875
• Device Sequence Number: 1
• Product Code: HCG
• UDI-Device Identifier: 00814548013787
• UDI-Public: 00814548013787
• Combination Product (y/n): Y
• 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: Physician
• Type of Report: Initial
• Report Date: 01/01/2005,04/05/2019

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: Health Professional
• Device Catalogue Number: RBYPOD5
• Device Lot Number: F75467
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 01/01/2005
• Date Report to Manufacturer: 01/10/2005
• Initial Date Manufacturer Received: 04/05/2019
• Initial Date FDA Received: 05/02/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/07/2017
• 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: 42 YR