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

Model Number	RBYPOD5-A
Medical Device Problem Codes	Physical Resistance/Sticking (4012); Premature Separation (4045)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/27/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Evaluation of the returned pod coil confirmed that the embolization coil was detached from the pusher assembly.Further evaluation revealed that the pet lock was intact on the proximal end of the pusher assembly, the pull wire was in its initial position within the pusher assembly ddt, and the embolization coils proximal constraint sphere was in its initial position within the pusher assembly ddt.This indicates that detached embolization coil was likely a result of the sr component fracturing.If the pod coil is forcefully retracted against resistance, the sr component may fracture, and the embolization coil will detach.The root cause of resistance during the procedure 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.Placeholder.
Event or Problem Description
The patient was undergoing a coil embolization procedure in the splenic artery using pod coils and a lantern delivery microcatheter (lantern).During the procedure, while advancing a pod5 to the target location, the physician experienced resistance.Subsequently, the physician noticed that the pod5 was too small; therefore, the pod5 was re-sheathed.The physician then attempted to use a pod6 but noticed it was too big; therefore, the pod6 was removed.Next, the physician decided to re-use the previously re-sheathed pod5 and placed it further down the vessel.While advancing the pod5, the physician experienced resistance.Subsequently, while placing the pod5 in the target location, the lantern kicked back in the vessel.The physician then decided to retract the pod5 so that the lantern can be advanced further down the vessel.While retracting the pod5, it unintentionally detached inside the lantern.Therefore, the physician used the pusher assembly of the pod5 to successfully push the detached pod5 into the target location.The procedure was completed using seven ruby coils, three pod packing coils, one pod coil and the same lantern.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: 12674766
• Report Number: 3005168196-2021-02347
• Device Sequence Number: 1181346
• Product Code: HCG
• UDI-Device Identifier: 00814548019604
• UDI-Public: 00814548019604
• Combination Product (Y/N): Y
• Initial Reporter Country: CA
• PMA/510(K) Number: K173614
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2021
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 10/21/2021
• 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 Model Number: RBYPOD5-A
• Device Catalogue Number: RBYPOD5
• Device Lot Number: F106958
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/04/2021
• Was the Report Sent to FDA?: Yes
• Date Report to Manufacturer: 01/10/2005
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/27/2021
• Initial Report FDA Received Date: 10/21/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 50 YR
• Date Report Sent to FDA: 01/01/2005