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

Catalog Number RBY2C0825

Device Problems Positioning Failure (1158); Physical Resistance (2578); Device Operates Differently Than Expected (2913)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 11/16/2017

Event Type  malfunction  

Manufacturer Narrative

Please note that the following device code also applies to this complaint: (b)(4).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 number: 3005168196-2017-02211.The hospital disposed of the device.

Event Description

The patient was undergoing a coil embolization procedure in the internal iliac artery using ruby coils and a lantern delivery microcatheter (lantern).During the procedure, the physician advanced a ruby coil through the lantern and into the target vessel; however, the ruby coil would not take its intended shape.After the ruby coil was advanced and retracted several times, it unintentionally detached.The physician mentioned experiencing resistance while retracting the ruby coil within the lantern.A syringe was then placed on the back of the lantern for negative suction and both the lantern and detached ruby coil were pulled out of the patient.Thereafter, the procedure was successfully completed using additional coils and another microcatheter.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: 7110105
• MDR Text Key: 95201402
• Report Number: 3005168196-2017-02210
• Device Sequence Number: 1
• Product Code: HCG
• UDI-Device Identifier: 00814548012971
• UDI-Public: 00814548012971
• 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: 11/16/2017

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: Physician
• Device Catalogue Number: RBY2C0825
• Device Lot Number: F78494
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 11/16/2017
• Initial Date FDA Received: 12/12/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/04/2017
• 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: 64 YR
• Patient Weight: 125