MAUDE Adverse Event Report: PENUMBRA, INC. POD6; HCG, KRD

Catalog Number	RBYPOD6
Medical Device Problem Code	Failure to Fold (1255)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	02/18/2019
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: 3005168196-2019-00503; 3005168196-2019-00504.
Event or Problem Description
The patient was undergoing a coil embolization procedure in the right inferior mesenteric artery (rima) using a pod6, pod8 and a pod packing coil (pod pc).During the procedure, the physician advanced the pod6 and pod8 in the target vessel using a non-penumbra microcatheter; however, both coils would not take their intended shape.Therefore, the pod6 and pod8 were removed.After that, the physician successfully implanted a ruby coil and a pod pc in the target vessel.However, after performing an angiographic run, the physician noticed that part of the pod pc migrated out of the vessel.Therefore, the physician used a snare device to remove the pod pc.The procedure was completed at this point and no additional coils were placed.There was no report of an adverse effect to the patient.

• Brand Name: POD6
• Common Device Name: HCG, KRD
• Manufacturer (Section D): PENUMBRA, INC.; one penumbra place; alameda CA 94502
• MDR Report Key: 8434907
• Report Number: 3005168196-2019-00502
• Device Sequence Number: 14122052
• Product Code: HCG
• UDI-Device Identifier: 00814548013817
• UDI-Public: 00814548013817
• Combination Product (Y/N): Y
• Initial Reporter State: OR
• Initial Reporter Country: US
• PMA/510(K) Number: K141134
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 02/18/2019
• 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: 01/18/2025
• Device Catalogue Number: RBYPOD6
• Device Lot Number: F73901
• Was Device Available for Evaluation?: No
• 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: 02/18/2019
• Initial Report FDA Received Date: 03/19/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 15 MO
• Date Report Sent to FDA: 01/01/2005