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

Catalog Number	RBYPOD8
Medical Device Problem Code	Premature Separation (4045)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	07/24/2018
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 product lot number was not provided; therefore, the manufacturing records could not be reviewed.This report is associated with mfr report number: 3005168196-2018-01659.
Event or Problem Description
The patient was undergoing a coil embolization procedure to treat a pulmonary arteriovenous malformation (avm) using a pod8 and a lantern delivery microcatheter (lantern).During the procedure, while attempting to place a pod8 into the target vessel using a lantern, the pod8 unintentionally detached inside the lantern.Therefore, the physician removed the lantern containing the detached coil.The procedure was completed using a new lantern and three ruby coils.It is unknown whether or not the first lantern was damaged after removal.There was no report of an adverse effect to the patient.

• Brand Name: POD8
• Common Device Name: HCG, KRD
• Manufacturer (Section D): PENUMBRA, INC.; one penumbra place; alameda CA 94502
• MDR Report Key: 7806134
• Report Number: 3005168196-2018-01660
• Device Sequence Number: 1536397
• Product Code: HCG
• UDI-Device Identifier: 00814548013831
• UDI-Public: 00814548013831
• Combination Product (Y/N): Y
• Initial Reporter State: MN
• Initial Reporter Country: US
• PMA/510(K) Number: K141134
• 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): 07/24/2018
• 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 Catalogue Number: RBYPOD8
• 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: 07/24/2018
• Initial Report FDA Received Date: 08/22/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Date Report Sent to FDA: 01/01/2005