MAUDE Adverse Event Report: PENUMBRA, INC. POD5; HCG, KRD

Catalog Number	RBYPOD5
Medical Device Problem Codes	Bent (1059); Kinked (1339); Physical Resistance (2578); Device Handling Problem (3265)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	01/18/2018
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 number: 3005168196-2018-00340, 3005168196-2018-00341.
Event or Problem Description
The patient was undergoing a coil embolization procedure to treat an endoleak using a lantern delivery microcatheter (lantern), ruby coils, and pod5s.During the procedure, the hospital technician felt resistance while advancing a ruby coil and then a pod5 through the lantern.The hospital technician continued to try to advance the coils, and consequently the pusher wires of a ruby coil and a pod5 became kinked/bent.The pod5 and ruby coil were therefore removed, and the physician also removed the lantern from the non-penumbra sheath.Upon removal, the lantern was found to be kinked, and the procedure was therefore completed using a new lantern, the same sheath, and additional ruby coils.It was reported that the lantern may have become kinked as the physician was repositioning it without using a guidewire, prior to attempting to place the pod5 and ruby coil.There was no report of an adverse effect to the patient.
Additional Manufacturer Narrative
Device manufacture date (mm/dd/yyyy) was incorrectly reported on the initial mfr report and is being corrected on this follow-up #1 mfr report.This report is associated with mfr report number: 3005168196-2018-00340, 3005168196-2018-00341.

• Brand Name: POD5
• Common Device Name: HCG, KRD
• Manufacturer (Section D): PENUMBRA, INC.; one penumbra place; alameda CA 94502
• MDR Report Key: 7268478
• Report Number: 3005168196-2018-00342
• Device Sequence Number: 11291928
• Product Code: HCG
• UDI-Device Identifier: 00814548013787
• UDI-Public: 00814548013787
• Combination Product (Y/N): N
• Initial Reporter State: CA
• 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: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 01/18/2018

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: Health Professional
• Device Expiration Date: 02/01/2025
• Device Catalogue Number: RBYPOD5
• Device Lot Number: F74230
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 01/18/2018
• Supplement Date Received by Manufacturer: 01/18/2018
• Initial Report FDA Received Date: 02/13/2018
• Supplement Report FDA Received Date: 05/30/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 76 YR