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

Catalog Number RBY2C1660

Device Problems Bent (1059); Physical Resistance (2578)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 11/20/2017

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.The hospital discarded the device.

Event Description

The patient was undergoing a coil embolization procedure using ruby coils.During the procedure, while attempting to insert a ruby coil into a lantern delivery microcatheter (lantern), the hospital technologist experienced resistance and subsequently, the ruby coil pusher assembly became bent; therefore, it was removed.The procedure was completed using a new ruby coil and the same lantern.There was no report of an adverse effect to the patient.

Manufacturer Narrative

Corrected labeled for single use? from no to yes.

• 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: 7131124
• MDR Text Key: 95909397
• Report Number: 3005168196-2017-02227
• Device Sequence Number: 1
• Product Code: HCG
• UDI-Device Identifier: 00814548013053
• UDI-Public: 00814548013053
• 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 Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 11/20/2017

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
• Device Operator: Radiologic Technologist
• Device Expiration Date: 06/26/2021
• Device Catalogue Number: RBY2C1660
• Device Lot Number: A36477
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 11/20/2017
• Initial Date FDA Received: 12/19/2017
• Supplement Dates Manufacturer Received: 11/20/2017
• Supplement Dates FDA Received: 06/05/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/28/2013
• 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: 62 YR
• Patient Weight: 94