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

Catalog Number RBY2C1035-A

Device Problems Detachment Of Device Component (1104); Material Disintegration (1177); Physical Resistance (2578)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 09/01/2016

Event Type  Injury  

Manufacturer Narrative

Results: the ruby coil¿s embolization coil stretch resistant wire (sr-wire) was fractured and the embolization coil was unraveled.Conclusions: evaluation of the second ruby coil used in the procedure revealed that the ruby coil¿s sr-wire was fractured.This type of damage typically occurs due to improper handling during use.If the device is forcefully retracted against resistance, damage such as this may occur.If the sr-wire becomes fractured, it will allow the embolization coil to detach.Evaluation of the returned lantern delivery microcatheter (lantern) revealed that the distal tip was ovalized.This type of damage typically occurs due to improper handling during use.If the lantern is forcefully gripped or otherwise compressed during insertion, or the peel-able sheath is not used during insertion, damage such as this may occur.The ovalization on the distal tip of the lantern likely contributed to the resistance that was experienced by the physician during retraction.There was no visible damage to the non-penumbra device; however, the ruby coil¿s embolization coil with the fractured sr-wire was stuck inside.The retrieval of the coil by the stent may have contributed to the unraveling of the coil.The first ruby coil used in the complaint and the pusher assembly of the second ruby coil used in the complaint were not returned for evaluation.All penumbra catheters and coils are inspected during in-process inspection and during quality inspection after manufacturing.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: report 3005168196-2016-01400.Report 3005168196-2016-01403.

Event Description

The patient was undergoing a coil embolization procedure using ruby coils.During the procedure, the physician experienced resistance while advancing a ruby coil through a lantern delivery microcatheter (lantern), and the ruby coil pusher assembly became bent; therefore it was removed.The physician then advanced a new ruby coil to the target vessel using the same lantern; however, the physician wanted to reposition the ruby coil and therefore retracted the ruby coil quickly with resistance, causing it to shred apart.The ruby coil unintentionally detached in the patient body, therefore, the physician used a snare device to retrieve all the parts of the detached ruby coil from the patient.The procedure was completed using a new ruby coil and additional non-penumbra coils, and the same lantern.The physician flushed between each coil and did not use a rotating hemostasis valve.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: kathleen kidd ; one penumbra place; alameda, CA 94502 ; 5107483200
• MDR Report Key: 5990646
• MDR Text Key: 56043214
• Report Number: 3005168196-2016-01401
• 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: 09/01/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/30/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Physician
• Device Expiration Date: 05/31/2023
• Device Catalogue Number: RBY2C1035-A
• Device Lot Number: F64044
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/27/2016
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 09/01/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/21/2015
• 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 Outcome(s): Required Intervention