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

Catalog Number RBY4C2060

Device Problems Bent (1059); Kinked (1339); Physical Resistance (2578); Device Handling Problem (3265)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 01/18/2018

Event Type  malfunction  

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, 3005168196-2018-00342.

Event 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.

• Brand Name: RUBY COIL
• Type of Device: HCG, KRD
• Manufacturer (Section D): PENUMBRA, INC.; one penumbra place; alameda CA 94502
• Manufacturer (Section G): PENUMBRA, INC.; one penumbra place; alameda CA 94502
• Manufacturer Contact: veronica farris ; one penumbra place; alameda, CA 94502 ; 5107483200
• MDR Report Key: 7268476
• MDR Text Key: 100269007
• Report Number: 3005168196-2018-00341
• Device Sequence Number: 1
• Product Code: HCG
• UDI-Device Identifier: 00814548013251
• UDI-Public: 00814548013251
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K120330
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 01/18/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/13/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: RBY4C2060
• Device Lot Number: F74998
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 01/18/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/15/2017
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Age: 76 YR