MAUDE Adverse Event Report: PENUMBRA, INC. POD 3; HCG

Catalog Number	RBYPOD3
Medical Device Problem Code	Failure to Fold (1255)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	09/04/2019
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.
Event or Problem Description
The patient was undergoing a coil embolization procedure in the left gonadal vein using pod10s and pod3s.During the procedure, a hospital technologist noticed the pod10 was kinked upon removal from its packaging hoop.The damage to the pod10 was found prior to use, and therefore, it was not used in the procedure.The physician then opened and placed another pod10.Next, while advancing and positioning a pod3 in the target vessel using a non-penumbra microcatheter, the pod3 would not take its intended shape to in the vessel; therefore, it was removed.The procedure was completed using another pod3 and the same microcatheter.There was no report of an adverse effect to the patient.

• Brand Name: POD 3
• Common Device Name: HCG
• Manufacturer (Section D): PENUMBRA, INC.; one penumbra place; alameda CA 94502
• MDR Report Key: 9146053
• Report Number: 3005168196-2019-01844
• Device Sequence Number: 16851957
• Product Code: HCG
• UDI-Device Identifier: 00814548019581
• UDI-Public: 00814548019581
• Combination Product (Y/N): Y
• Initial Reporter State: OR
• 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): 09/04/2019
• 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: RBYPOD3
• Device Lot Number: F89923
• 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: 09/04/2019
• Initial Report FDA Received Date: 10/02/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 55 YR
• Date Report Sent to FDA: 01/01/2005