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

Catalog Number	RBYPOD3
Medical Device Problem Codes	Device Damaged Prior to Use (2284); Material Twisted/Bent (2981)
Health Effect - Clinical Code	No Patient Involvement (2645)
Date of Event	09/11/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Results: the pod 3 was kinked approximately 5.0 cm from the proximal end of the pusher assembly.Conclusions: evaluation of the returned pod3 revealed a kinked device.If the pod3 is forcefully manipulated or handled during removal from the packaging, damage such as a kink may occur.Penumbra coils are visually inspected during in-process inspection and during quality inspection after manufacturing.The manufacturing records for this lot were reviewed and did not reveal any outstanding discrepancies, design, or quality concerns.
Event or Problem Description
The patient was undergoing a coil embolization procedure using pod3s.During the procedure, the physician inserted a lantern delivery microcatheter (lantern) into patient¿s body and was checking the lantern positioning on the screen.During the same time, the hospital technologist pulled a pod3 out of its dispenser hoop and noticed the pusher wire was bent; therefore, it was not used in the procedure.It is unclear if the pod3 pusher wire was bent prior to retracting it out of the packaging hoop.The procedure was completed using a new pod3 with the same lantern.

• Brand Name: POD3
• Common Device Name: HCG, KRD
• Manufacturer (Section D): PENUMBRA, INC.; one penumbra place; alameda CA 94502
• MDR Report Key: 7958000
• Report Number: 3005168196-2018-01989
• Device Sequence Number: 11141475
• Product Code: HCG
• UDI-Device Identifier: 00814548019581
• UDI-Public: 00814548019581
• Combination Product (Y/N): Y
• Initial Reporter State: NE
• 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): 09/11/2018
• 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: 04/22/2022
• Device Catalogue Number: RBYPOD3
• Device Lot Number: F82988
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/25/2018
• 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: 09/11/2018
• Initial Report FDA Received Date: 10/11/2018
• 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