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

Catalog Number RBY2C1035

Device Problems Kinked (1339); Device Handling Problem (3265)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 12/21/2017

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 numbers: 3005168196-2018-00158, 3005168196-2018-00160.The hospital discarded the device.

Event Description

The patient was undergoing a coil embolization procedure in the left hypogastric artery using ruby coils and pod packing coils (podjs).During the procedure, the physician deployed and detached a ruby coil in the target vessel using a lantern delivery microcatheter (lantern).While attempting to advance two other ruby coils through the lantern, the hospital technologists inadvertently kinked the coils pusher assemblies; therefore, they were removed.The procedure continued by placing a new ruby coil in the target vessel.While attempting to advance a podj through the lantern, the hospital technologist inadvertently pulled the lantern out of the vessel which caused the coil to unintentionally detach inside the lantern.Therefore, the lantern containing the detached coil was removed and the coil flushed out.The procedure was completed using another podj and the same lantern.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 Contact: veronica farris ; one penumbra place; alameda, CA 94502 ; 5107483200
• MDR Report Key: 7200840
• MDR Text Key: 98014738
• Report Number: 3005168196-2018-00159
• Device Sequence Number: 1
• Product Code: HCG
• UDI-Device Identifier: 00814548013008
• UDI-Public: 00814548013008
• 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: Physician
• Type of Report: Initial
• Report Date: 12/21/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/17/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: RBY2C1035
• Device Lot Number: F70599
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/21/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/14/2016
• 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: 57 YR