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

Model Number	RBYPOD4
Medical Device Problem Code	Separation Failure (2547)
Health Effect - Clinical Codes	No Consequences Or Impact To Patient (2199); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/02/2020
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 using pod coils and a lantern delivery microcatheter (lantern).During the procedure, the physician advanced a pod coil into the target vessel using the lantern; however, the pod coil failed to detach and was therefore removed.No additional information regarding the completion of the procedure was provided.There was no report of an adverse effect to the patient.
Additional Manufacturer Narrative
Please note that the following section is being updated based on additional information provided by a penumbra sales representative on (b)(6) 2020: 1.Section b.Box 5.Describe event or problem results: the pet lock was intact on the proximal end of the pusher assembly.The pusher assembly was fractured approximately 105.0 cm from its proximal end.The embolization coil was detached from its pusher assembly.Conclusions: evaluation of the returned pod revealed that the pet lock was intact on the proximal end of the pusher assembly.This indicates that the handle used in the procedure may not have been properly seated on the proximal end of the pusher assembly during the attempt to detach the coil.Further evaluation of the returned pod revealed a fractured pusher assembly and a detached embolization coil.If the pod is forcefully advanced against resistance, damage such as a kink and subsequently fracture may occur.If the two fractured segments are separated, the embolization coil will detach from its pusher assembly.Based on the returned condition, the root cause of the reported complaint could not be determined.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.
Event or Problem Description
The patient was undergoing a coil embolization procedure in the hepatic artery using pod coils, a ruby coil detachment handle (handle) and a lantern delivery microcatheter (lantern).During the procedure, the physician advanced a pod coil into the target vessel using the lantern and attempted to detach it using the handle; however, the pod coil failed to detach.Therefore, the pod coil was removed.The procedure was completed using another pod coil, ruby coils and the same handle.There was no report of an adverse effect to the patient.

• Brand Name: POD
• Common Device Name: HCG, KRD
• Manufacturer (Section D): PENUMBRA, INC.; one penumbra place; alameda CA 94502
• MDR Report Key: 10623563
• Report Number: 3005168196-2020-01641
• Device Sequence Number: 1282149
• Product Code: HCG
• UDI-Device Identifier: 00814548013756
• UDI-Public: 00814548013756
• Combination Product (Y/N): Y
• Initial Reporter Country: AS
• 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
• Report Date (Section B): 09/03/2020
• 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: RBYPOD4
• Device Catalogue Number: RBYPOD4
• Device Lot Number: F96674
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/16/2020
• Was the Report Sent to FDA?: Yes
• Date Report to Manufacturer: 01/10/2005
• Initial Date Received by Manufacturer: 09/03/2020
• Supplement Date Received by Manufacturer: 10/05/2020
• Initial Report FDA Received Date: 10/02/2020
• Supplement Report FDA Received Date: 12/29/2020
• 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