MAUDE Adverse Event Report: PENUMBRA, INC. POD 4; HCG, KRD

Catalog Number	RBYPOD4
Medical Device Problem Code	Premature Separation (4045)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	12/21/2018
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 pod4s.During the procedure, the physician advanced the first pod4 into the target vessel using a lantern delivery microcatheter (lantern).However, the lantern's tip had kicked out of the vessel; therefore, the physician retracted the pod4 back into the lantern to re-position the lantern within the target vessel.While re-advancing the pod4 through the lantern, the pod4 unintentionally detached within the lantern.Subsequently, the lantern and pod4 were removed from the patient, the pod4 was removed from the lantern, and the pod4 was no longer used in the procedure.The procedure was completed using a new pod4, the same lantern, and eleven additional coils.There was no report of an adverse effect to the patient.
Additional Manufacturer Narrative
Results: the pet lock was intact on the proximal end of the pusher assembly.The pusher assembly was bent at approximately 49.0 cm from the proximal end.The embolization coil was detached from the distal detachment tip (ddt) and had offset coil winds.The pull wire was advanced distal to ddt.Conclusions: evaluation of the returned pod4 confirmed that the embolization coil was detached from its pusher assembly.If the device is retracted against resistance, the pusher assembly may elongate beyond the reach of the pull wire and the coil may detach from the pusher assembly.Further evaluation revealed some offset coil winds on the embolization coil and a bend on the pusher assembly.These damages were likely incidental to the reported failure.The lantern identified in the complaint was not returned for evaluation.The root cause of the initial resistance could not be determined.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.

• Brand Name: POD 4
• Common Device Name: HCG, KRD
• Manufacturer (Section D): PENUMBRA, INC.; one penumbra place; alameda CA 94502
• MDR Report Key: 8321783
• Report Number: 3005168196-2019-00221
• Device Sequence Number: 2357412
• Product Code: HCG
• UDI-Device Identifier: 00814548013756
• UDI-Public: 00814548013756
• 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): 01/09/2019
• 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: 03/15/2024
• Device Catalogue Number: RBYPOD4
• Device Lot Number: F68515
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/25/2019
• Was the Report Sent to FDA?: Yes
• Date Report to Manufacturer: 01/10/2005
• Initial Date Received by Manufacturer: 01/09/2019
• Supplement Date Received by Manufacturer: 04/04/2019
• Initial Report FDA Received Date: 02/08/2019
• Supplement Report FDA Received Date: 05/04/2019
• 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