MAUDE Adverse Event Report: PENUMBRA, INC. POD 14; HCG, KRD

Catalog Number	RBYPOD14
Medical Device Problem Codes	Material Deformation (2976); Physical Resistance/Sticking (4012); Separation Problem (4043)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	02/22/2019
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 pod14s.During the procedure, the physician advanced a lantern delivery microcatheter (lantern) into the target vessel.The physician then reported feeling resistance while advancing the first pod14 into the lantern.The pod14 pusher wire then became kinked and the coil unintentionally detached within the lantern.The pod14 was then removed from the lantern and was no longer used in the procedure.The procedure was completed using seven non-penumbra coils and the same lantern.There was no report of an adverse effect to the patient.
Additional Manufacturer Narrative
Results: the pet lock was damaged but intact at the proximal end of the pusher assembly.The pusher assembly was fractured approximately 34.0 cm from the proximal end.The pusher assembly was kinked approximately 9.0 cm, 32.5 cm, 35.5 cm, 70.0 cm, 87.0 cm, 111.0 cm and 141.5 cm from the proximal end.The embolization coil was detached from the pusher assembly distal detachment tip (ddt).The embolization coil was undamaged.The introducer sheath was undamaged.The pull wire within the pusher assembly was fractured approximately 170.5 cm from the proximal end.Conclusions: evaluation of the returned pod14 confirmed a fractured pusher assembly and detached embolization coil.It was reported that the physician felt resistance while advancing the pod14 into the lantern.If the device is forcefully advanced against resistance, damage such as a kink may occur.Subsequently, if the kinked device is further manipulated, damage such as a fracture may occur.If the pusher assembly becomes fractured and two segments are separated, the pull wire may be retracted out of the distal detachment tip (ddt) and the embolization coil will detach from its pusher assembly.Based on the reported complaint, the root cause of the initial resistance experienced during the procedure could not be determined.Further evaluation revealed kinks along the pusher assembly and a fractured pull wire.Some of these damages were 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.

• Brand Name: POD 14
• Common Device Name: HCG, KRD
• Manufacturer (Section D): PENUMBRA, INC.; one penumbra place; alameda CA 94502
• MDR Report Key: 8453247
• Report Number: 3005168196-2019-00571
• Device Sequence Number: 11510380
• Product Code: HCG
• UDI-Device Identifier: 00814548019673
• UDI-Public: 00814548019673
• Combination Product (Y/N): Y
• Initial Reporter Country: JA
• PMA/510(K) Number: K173614
• 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): 02/27/2019
• 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: 09/16/2026
• Device Catalogue Number: RBYPOD14
• Device Lot Number: F85917
• 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: 02/27/2019
• Supplement Date Received by Manufacturer: 04/24/2019
• Initial Report FDA Received Date: 03/26/2019
• Supplement Report FDA Received Date: 05/14/2019
• 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