MAUDE Adverse Event Report: PENUMBRA, INC. POD5; HCG, KRD

Catalog Number	RBYPOD5
Medical Device Problem Codes	Failure to Advance (2524); Physical Resistance (2578)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	10/01/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The pod5 was kinked approximately 35.0, 45.0, and 47.0 cm from the proximal end of the pusher assembly.The embolization coil was intact with the pusher assembly.There was blood clotted onto the embolization coil preventing the coil from advancing out of the introducer sheath.Evaluation of the returned pod5 revealed significant thrombus coagulated on the embolization coil.When the coagulated portion of the embolization coil was retracted into the introducer sheath, resistance was experienced and it was unable to be advanced out.This thrombus may have contributed to the difficulty manipulating the coil during coil placement.Evaluation of the returned pod4 revealed fulcrum of the distal detachment tip (ddt) was bent and the proximal constraint sphere had been pushed out of the ddt.This damage contributed to difficulty advancing the embolization coil out of its introducer sheath during functional testing and likely contributed to the difficulty advancing the embolization coil during the procedure.The root cause of this damage could not be determined.Further evaluation revealed kinks on both pusher assemblies.These kinks were likely a result of forcefully advancing the coil against resistance.Penumbra coils are 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.This report is associated with mfr report numbers: 3005168196-2017-01917.
Event or Problem Description
The patient was undergoing a coil embolization procedure in the splenic artery using a pod4 and a pod5.During the procedure, while attempting to advance a pod4 and a pod5 through a non-penumbra microcatheter, the physician experienced resistance and subsequently, the pod4 and pod5 would not advance out of the distal end of the microcatheter; therefore, they were removed.The procedure was completed using ruby coils and the same microcatheter.There was no report of an adverse effect to the patient.
Additional Manufacturer Narrative
Please note that the following section was incorrectly reported on the initial mfr report and is being corrected on this follow-up #01 mfr report: 1.Device manufacture date.This report is associated with mfr report number: 3005168196-2017-01917.

• Brand Name: POD5
• Common Device Name: HCG, KRD
• Manufacturer (Section D): PENUMBRA, INC.; one penumbra place; alameda CA 94502
• MDR Report Key: 6996718
• Report Number: 3005168196-2017-01916
• Device Sequence Number: 19083992
• Product Code: HCG
• UDI-Device Identifier: 00814548013787
• UDI-Public: 00814548013787
• Combination Product (Y/N): Y
• Initial Reporter State: AL
• 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): 10/05/2017
• 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: Physician
• Device Expiration Date: 10/02/2024
• Device Catalogue Number: RBYPOD5
• Device Lot Number: F71913
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/11/2017
• Was the Report Sent to FDA?: Yes
• Date Report to Manufacturer: 01/10/2005
• Initial Date Received by Manufacturer: 10/05/2017
• Supplement Date Received by Manufacturer: 01/14/2005
• Initial Report FDA Received Date: 11/02/2017
• Supplement Report FDA Received Date: 02/08/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 38 YR
• Patient Weight: 86
• Date Report Sent to FDA: 01/01/2005