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

Catalog Number	RBYPODJ15
Medical Device Problem Code	Detachment Of Device Component (1104)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	03/13/2018
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.The hospital disposed of the device.
Event or Problem Description
The patient was undergoing a coil embolization procedure in the renal artery using pod packing coils (podj¿s).During the procedure, the physician deployed and detached six ruby coils in the target vessel using a lantern delivery microcatheter (lantern).While attempting to deploy a podj in the aneurysm, the lantern kicked out the aneurysm; therefore, the physician decided to remove the podj in order to reposition the lantern.However, the podj unintentionally detached in the hub of the lantern during retraction and therefore, the physician pulled the detached ruby coil from the hub of the lantern.Upon repositioning the lantern, the physician attempted to advance a new podj in the aneurysm; however, resistance was encountered approximately half way into the aneurysm and the physician assumed that the aneurysm was getting packed at this point.Therefore, the podj was removed intact and the procedure was completed using a ruby coil and the same lantern.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: 7407343
• Report Number: 3005168196-2018-00725
• Device Sequence Number: 11268526
• Product Code: HCG
• UDI-Device Identifier: 00814548016702
• UDI-Public: 00814548016702
• Combination Product (Y/N): Y
• 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: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 03/13/2018
• 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: Physician
• Device Expiration Date: 07/24/2025
• Device Catalogue Number: RBYPODJ15
• Device Lot Number: C04657
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Date Report to Manufacturer: 01/10/2005
• Initial Date Received by Manufacturer: 03/13/2018
• Supplement Date Received by Manufacturer: 01/14/2005
• Initial Report FDA Received Date: 04/09/2018
• Supplement Report FDA Received Date: 06/03/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 54 YR
• Date Report Sent to FDA: 01/01/2005