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

Catalog Number	RBYPODJ30
Medical Device Problem Codes	Detachment Of Device Component (1104); Mechanical Jam (2983); Device Handling Problem (3265)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	06/13/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The product was not returned for evaluation.Without the return of the device, the root cause of the problem cannot be determined.The manufacturing records for this lot were reviewed and did not reveal any outstanding discrepancies, design, or quality concerns.This report is associated with mfr report numbers: 3005168196-2018-01343, 3005168196-2018-01345.
Event or Problem Description
The patient was undergoing a coil embolization procedure in the left hepatic artery using pod packing coils (podj¿s) and a lantern delivery microcatheter (lantern).During the procedure, while advancing a podj through a lantern, the podj got stuck inside the lantern at the point where the lantern was exiting the guide catheter.Therefore, the podj was pulled back and partially re-sheathed.However, upon removal from the rotating hemostasis valve (rhv), the podj became detached.It appeared that there was some excessive manipulation on the podj.The physician then made a second attempt to deliver another podj; however, the podj became stuck at the same position in the lantern; therefore, the physician decided to remove it.Upon retraction, the podj unintentionally detached inside the lantern and became stuck.The physician attempted to push the detached podj, but was unable to push it forward using the pusher assembly or flush it forward.Therefore, the lantern containing the detached podj was removed from the patient.Upon removal, it was noticed that the lantern was kinked.The procedure was completed using another microcatheter and two ruby coils.There was no report of an adverse effect to the patient.

• Brand Name: POD PACKING COIL
• Common Device Name: HCG, KRD
• Manufacturer (Section D): PENUMBRA, INC.; one penumbra place; alameda CA 94502
• MDR Report Key: 7664553
• Report Number: 3005168196-2018-01344
• Device Sequence Number: 2527485
• Product Code: HCG
• UDI-Device Identifier: 00814548016719
• UDI-Public: 00814548016719
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: K170852
• 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
• Report Date (Section B): 06/13/2018

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: Physician
• Device Expiration Date: 03/24/2026
• Device Catalogue Number: RBYPODJ30
• Device Lot Number: F82528
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/13/2018
• Initial Report FDA Received Date: 07/05/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1