MAUDE Adverse Event Report: PENUMBRA, INC. POD4; HCG, KRD

Model Number	RBYPOD4
Medical Device Problem Code	Failure to Fold (1255)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	11/01/2019
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 gastroduodenal artery (gda) using a pod4.During the procedure, while attempting to advance a pod4 into the target vessel using a non-penumbra microcatheter, the pod4 would not form its intended shape and the microcatheter would kick out of the gda.Therefore, the pod4 was removed.The procedure was completed using a pod packing coil (pod pc), a ruby coil and the same microcatheter.There was no report of an adverse effect to the patient.
Additional Manufacturer Narrative
Please note that the following section is being updated based on additional information provided by a penumbra sales representative on 6/10/2021: 1.Section b.Box 5.Describe event or problem.
Event or Problem Description
The patient was undergoing a coil embolization procedure in the gastroduodenal artery (gda) using a pod4 and a pod pc.During the procedure, while attempting to advance a pod4 into the target vessel using a non-penumbra microcatheter, the pod4 would not form its intended shape and the microcatheter would kick out of the gda.Therefore, the pod4 was removed.Next, while removing a pod pc out from the packaging, the hospital technologist noticed the pusher wire to be bent.The damage to the pod pc was found prior to use; therefore, it was not used in the procedure.The procedure was completed using a new pod packing coil (pod pc), a ruby coil and the same microcatheter.There was no report of an adverse effect to the patient.

• Brand Name: POD4
• Common Device Name: HCG, KRD
• Manufacturer (Section D): PENUMBRA, INC.; one penumbra place; alameda CA 94502
• MDR Report Key: 9377634
• Report Number: 3005168196-2019-02209
• Device Sequence Number: 11277902
• Product Code: HCG
• UDI-Device Identifier: 00814548013756
• UDI-Public: 00814548013756
• 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,Followup
• Report Date (Section B): 11/01/2019
• 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 Expiration Date: 02/07/2026
• Device Model Number: RBYPOD4
• Device Catalogue Number: RBYPOD4
• Device Lot Number: F81833
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Date Report to Manufacturer: 01/10/2005
• Initial Date Received by Manufacturer: 11/01/2019
• Supplement Date Received by Manufacturer: 07/10/2021
• Initial Report FDA Received Date: 11/26/2019
• Supplement Report FDA Received Date: 07/14/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 67 YR
• Date Report Sent to FDA: 01/01/2005