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

Catalog Number	RBYPOD8
Medical Device Problem Codes	Failure to Advance (2524); Physical Resistance/Sticking (4012)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	06/21/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
This device is available for return.A follow up mdr will be submitted upon completion of the device investigation.
Event or Problem Description
The patient was undergoing a coil embolization procedure in the right ipogastric artery using pod8.During the procedure, the physician experienced resistance after advancing the pod8 into a non-penumbra microcatheter; consequently, the pod8 became stuck and was unable to advance any further; therefore the pod8 was removed.The procedure was completed using two ruby coils and the same microcatheter.There was no report of adverse effect to the patient.
Additional Manufacturer Narrative
Please note that the following section was inadvertently missed on the initial mfr report and is being included on this follow-up #01 mfr report:(b)(4).1.Section g.Box 5.510(k) h3 other text : placeholder.
Additional Manufacturer Narrative
Results: the pet lock was intact on the proximal end of the pod8 pusher assembly.The pusher assembly was kinked approximately 87.0 and 123.0 cm from the proximal end.The embolization coil was detached from its pusher assembly inside its introducer sheath.The introducer sheath had coagulated blood inside the proximal end.The introducer sheath was kinked approximately 21.5 cm from its distal tip.Conclusions: evaluation of the returned pod8 revealed that the pet lock was intact, and the embolization coil was detached within its introducer sheath.If the device is forcefully retracted against resistance, the pusher assembly may elongate beyond the reach of its pull wire and result in the embolization coil detaching from its pusher assembly.The non-penumbra microcatheter identified in the complaint was not returned to penumbra for evaluation.Therefore, the root cause of reported resistance could not be determined.Further evaluation of the returned pod8 revealed that the pusher assembly and introducer sheath were kinked.The kink in the introducer sheath may have contributed to the embolization coil detaching within its introducer sheath.The kinks in the pusher assembly were likely incidental to the reported complaint and may have occurred during packaging of the device for returned to penumbra.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.H3 other text : placeholder.

• Brand Name: POD8
• Common Device Name: HCG, KRD
• Manufacturer (Section D): PENUMBRA, INC.; one penumbra place; alameda CA 94502
• MDR Report Key: 8821315
• Report Number: 3005168196-2019-01421
• Device Sequence Number: 3258455
• Product Code: HCG
• UDI-Device Identifier: 00814548013831
• UDI-Public: 00814548013831
• Combination Product (Y/N): Y
• Initial Reporter Country: IT
• PMA/510(K) Number: K141134
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 06/24/2019
• 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: RBYPOD8
• Device Lot Number: F88054
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/26/2019
• Was the Report Sent to FDA?: Yes
• Date Report to Manufacturer: 01/10/2005
• Initial Date Received by Manufacturer: 06/24/2019
• Supplement Date Received by Manufacturer: 06/24/2019; 08/14/2019
• Initial Report FDA Received Date: 07/24/2019
• Supplement Report FDA Received Date: 07/24/2019; 08/26/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 82 YR
• Date Report Sent to FDA: 01/01/2005