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

Catalog Number	RBYPOD8
Medical Device Problem Codes	Physical Resistance/Sticking (4012); Premature Separation (4045)
Health Effect - Clinical Code	No Patient Involvement (2645)
Date of Event	03/01/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device has been returned and the investigation results are pending.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 internal iliac artery (iia) using pod8s.While preparing to advance the pod8 into the patient, the physician flushed the pod8 with saline and advanced and retracted it within its sheath.While retracting the pod8 back to its initial position, the physician reported experiencing resistance.The pod8 then inadvertently detached within the sheath.The issue with the pod8 was found prior to use and therefore it was not used in the procedure.The procedure was completed using two additional pod8 coils and one non-penumbra coil.
Additional Manufacturer Narrative
Results: the pet lock was intact on the proximal end of the pusher assembly.The embolization coil was detached from the pusher assembly and had offset coil winds.The proximal constraint sphere was attached with the embolization coil.The pull wire was within the distal detachment tip (ddt).Conclusions: evaluation of the returned pod8 confirmed that the embolization coil was detached from the pusher assembly.If the device is forcefully retracted against resistance, the pusher assembly may stretch past the reach of the pull wire and the embolization coil may become detached from the distal detachment tip (ddt).The complaint indicated that the resistance was experienced while retracting the device within its introducer sheath.The introducer sheath was not returned for evaluation; therefore, the root cause of the initial resistance could not be determined.Further investigation revealed offset coil winds.Based on the return condition, this damage was likely incidental to the reported complaint and may have occurred during packaging for return to penumbra.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.Conclusions code 1: 4316- the investigation findings do not lead to a clear conclusion about the cause of initial resistance.

• Brand Name: POD8
• Common Device Name: HCG, KRD
• Manufacturer (Section D): PENUMBRA, INC.; one penumbra place; alameda CA 94502
• MDR Report Key: 8496220
• Report Number: 3005168196-2019-00655
• Device Sequence Number: 1062462
• Product Code: HCG
• UDI-Device Identifier: 00814548013831
• UDI-Public: 00814548013831
• Combination Product (Y/N): Y
• Initial Reporter Country: JA
• PMA/510(K) Number: K141134
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: distributor,foreign,health pr
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 03/11/2019
• 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: 06/16/2026
• Device Catalogue Number: RBYPOD8
• Device Lot Number: F84111
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/21/2019
• Was the Report Sent to FDA?: Yes
• Date Report to Manufacturer: 01/10/2005
• Initial Date Received by Manufacturer: 03/11/2019
• Supplement Date Received by Manufacturer: 04/30/2019
• Initial Report FDA Received Date: 04/09/2019
• Supplement Report FDA Received Date: 05/29/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Date Report Sent to FDA: 01/01/2005