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

Catalog Number	RBYPOD8
Medical Device Problem Codes	Failure to Advance (2524); Device Handling Problem (3265); Physical Resistance/Sticking (4012)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	08/15/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Please note that the following device code also applies to this complaint:(b)(4).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 splenic artery using a pod8.During the procedure, while attempting to advance a pod8 through a non-penumbra microcatheter, the physician experienced resistance and the pod8 would not properly advance through the microcatheter; therefore, the microcatheter and pod8 were removed.The procedure was completed using another microcatheter and ruby coils.It was reported that the non-penumbra microcatheter that the physician was using was incompatible with the pod8.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: 7877890
• Report Number: 3005168196-2018-01814
• Device Sequence Number: 13972300
• Product Code: HCG
• UDI-Device Identifier: 00814548013831
• UDI-Public: 00814548013831
• Combination Product (Y/N): Y
• Initial Reporter State: MO
• 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): 08/16/2018
• 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: 02/29/2024
• Device Catalogue Number: RBYPOD8
• Device Lot Number: F67969
• 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: 08/16/2018
• Initial Report FDA Received Date: 09/14/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 62 YR
• Patient Weight: 86
• Date Report Sent to FDA: 01/01/2005