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

Model Number	RBYPOD3-A
Medical Device Problem Code	Failure to Fold (1255)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	06/29/2020
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 renal artery using pod coils and a lantern delivery microcatheter (lantern).During the procedure, the physician successfully implanted several ruby coils using the lantern.While attempting to implant a pod coil, it was reported that the coil would not take its intended shape in the target vessel.Therefore, the pod coil was removed.The procedure was completed using a shorter ruby coil and the same lantern.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 its pusher assembly.The embolization coil was intact with its pusher assembly and had offset coil winds.Conclusions: evaluation of the returned pod coil revealed offset coil winds on the proximal end of the embolization coil.If the pod coil is forcefully manipulated against resistance, damage such as offset coil winds may occur.These offset coil winds likely contribute to the pod coil not taking its intended shape during the procedure.During the functional test, the pod coil was advanced out of its introducer sheath and a shape was present.The pod coil was then advanced through a demonstration lantern and a shape was present.Evaluation of the returned ruby coil revealed a functional device.During the functional test, the ruby coil was advanced out of its introducer sheath and through a demonstration lantern with resistance and a shape was present.While re-sheathing the ruby coil resistance was encountered, and offset coil winds were observed on the proximal end of the embolization coil.Further evaluation revealed bends throughout the length of the pusher assembly.These bends may have been incidental to the reported complaint and may have occurred during packaging of the device for return.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: POD
• Common Device Name: HCG, KRD
• Manufacturer (Section D): PENUMBRA, INC.; one penumbra place; alameda CA 94502
• MDR Report Key: 10323611
• Report Number: 3005168196-2020-01023
• Device Sequence Number: 16938597
• Product Code: HCG
• UDI-Device Identifier: 00814548019581
• UDI-Public: 00814548019581
• Combination Product (Y/N): Y
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K173614
• 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): 07/01/2020
• 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 Model Number: RBYPOD3-A
• Device Catalogue Number: RBYPOD3
• Device Lot Number: F89457
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/08/2020
• Was the Report Sent to FDA?: Yes
• Date Report to Manufacturer: 01/10/2005
• Initial Date Received by Manufacturer: 07/01/2020
• Supplement Date Received by Manufacturer: 10/15/2020
• Initial Report FDA Received Date: 07/24/2020
• Supplement Report FDA Received Date: 11/15/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 47 YR
• Date Report Sent to FDA: 01/01/2005