MAUDE Adverse Event Report: PENUMBRA, INC. POD3; HCG, KRD

Catalog Number	RBYPOD3
Medical Device Problem Code	Patient-Device Incompatibility (2682)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	07/19/2018
Type of Reportable Event	Malfunction
Additional 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: 3005168196-2018-01619.
Event or Problem Description
The patient was undergoing a coil embolization procedure using a pod3 and pod4.It was noted that this was an extremely high flow environment.During the procedure, the physician was unable to get the pod4 and pod3 to anchor.It was reported that the physician made multiple attempts but the coils kept running; therefore, they were removed.The procedure was completed using two ruby coils, a pod packing coil.There was no report of adverse effect to the patient.

• Brand Name: POD3
• Common Device Name: HCG, KRD
• Manufacturer (Section D): PENUMBRA, INC.; one penumbra place; alameda CA 94502
• MDR Report Key: 7794033
• Report Number: 3005168196-2018-01618
• Device Sequence Number: 19118423
• Product Code: HCG
• UDI-Device Identifier: 00814548019581
• UDI-Public: 00814548019581
• Combination Product (Y/N): Y
• Initial Reporter State: OH
• Initial Reporter Country: US
• PMA/510(K) Number: K173614
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 07/19/2018
• Report Date (Section F): 01/01/2005

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
• Operator of Device: Health Professional
• Device Expiration Date: 03/28/2026
• Device Catalogue Number: RBYPOD3
• Device Lot Number: F82605
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Date Report to Manufacturer: 01/10/2005
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/19/2018
• Initial Report FDA Received Date: 08/17/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 3 YR
• Patient Weight: 9
• Date Report Sent to FDA: 01/01/2005