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

Catalog Number RBY2C0435

Device Problems Bent (1059); Kinked (1339)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 01/23/2018

Event Type  malfunction  

Manufacturer Narrative

The product was disposed of by the hospital and is no longer available for return.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: 3005168196-2018-00382, 3005168196-2018-00383, 3005168196-2018-00384.The hospital discarded the device.

Event Description

The patient was undergoing a coil embolization procedure in the left internal iliac artery using ruby coils and pod6.During the procedure, while attempting to place a ruby coil between the arterial and venous connection in a figure 8 fashion using a lantern delivery microcatheter (lantern), the physician aggressively applied forward tension on the lantern and moved the coil in and out the treatment site.Consequently, the pusher assembly pet lock became damaged and subsequently, the ruby coil unintentionally detached.Therefore, the physician attached a syringe to the back of the lantern and pulled negative pressure back.Thus, the detached coil was aspirated out.It was reported that the same issue occurred with another ruby coil and pod6.Both coils were also aspirated out after the unintentional detachment.While attempting to advance a new ruby coil through the lantern, the ruby coil pusher assembly became bent and kinked after aggressive forward and backward motion.Therefore, the ruby coil and lantern were removed.The procedure was completed using a new lantern and additional ruby coils.It should be noted that there was no noted damage or issue with the initial lantern.The physician just wanted to start fresh with a new lantern.Additionally, 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: 7451497
• MDR Text Key: 106255692
• Report Number: 3005168196-2018-00825
• Device Sequence Number: 1
• Product Code: HCG
• UDI-Device Identifier: 00814548012889
• UDI-Public: 00814548012889
• 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
• Report Date: 01/23/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/23/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Physician
• Device Catalogue Number: RBY2C0435
• Device Lot Number: F72078
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/23/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/14/2016
• 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: 29 YR
• Patient Weight: 86