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

Model Number	RBYPOD12-A
Medical Device Problem Codes	Material Deformation (2976); Physical Resistance/Sticking (4012)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/12/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
This device is available for return.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 using pod coils, a lantern delivery microcatheter (lantern), and non-penumbra catheter.It was reported the patient anatomy was mildly tortuous.During the procedure, a pod coil wound itself when moving forward in the hub of the lantern, and the physician re-sheathed the coil.The pusher assembly was stuck when attempting to re-advance, and a part of the pusher assembly was bent.Therefore, the coil was removed.The procedure was completed using a new pod coil, thirty-one ruby coils, and the same lantern.There was no report of an adverse effect to the patient.
Additional Manufacturer Narrative
Evaluation of the returned pod12 could not confirm the reported complaint.Further evaluation revealed that the pusher assembly mid-joint was retracted proximal to the introducer sheath friction lock.If this occurs, resistance may be experienced during advancement and the device may not advance at all.This damage was incidental to the reported complaint and likely occurred during the re-sheath of the pod12 as mentioned in the complaint.This damage also prevented the pod12 from being functionally tested during evaluation.During the functional test, resistance was encountered while attempting to advance the pusher assembly through its introducer sheath from its returned position, and the pusher assembly could not be advanced at all.Further evaluation revealed multiple kinks throughout the length of the pusher assembly.This damage was incidental to the reported complaint.Some of these kinks likely occurred due to forceful advancement against resistance that occurred due to the pusher assembly being proximal to introducer sheath friction lock.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.Section h.Box 6.Conclusions code 1: 4316 - the investigation findings do not lead to a clear conclusion about the root cause of the reported complaint.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: 11975107
• Report Number: 3005168196-2021-01296
• Device Sequence Number: 4229426
• Product Code: HCG
• UDI-Device Identifier: 00814548019666
• UDI-Public: 00814548019666
• 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): 05/13/2021
• 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: 09/02/2026
• Device Model Number: RBYPOD12-A
• Device Catalogue Number: RBYPOD12
• Device Lot Number: F85649
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/10/2021
• Was the Report Sent to FDA?: Yes
• Date Report to Manufacturer: 01/10/2005
• Initial Date Received by Manufacturer: 05/13/2021
• Supplement Date Received by Manufacturer: 06/22/2021
• Initial Report FDA Received Date: 06/10/2021
• Supplement Report FDA Received Date: 07/07/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 81 YR
• Date Report Sent to FDA: 01/01/2005