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

Catalog Number RBY2C0320

Device Problems Structural Problem (2506); Device Operates Differently Than Expected (2913)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 10/06/2016

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 disposed of the device.

Event Description

The patient was undergoing a coil embolization procedure to treat a duodenal bleed using ruby coils.During the procedure, after advancing the first ruby coil in the target vessel using a lantern delivery microcatheter (lantern), the physician noticed the ruby coil was unable to take its intended shape in the target vessel; therefore it was removed.The procedure was successfully completed using three new ruby coils and the same lantern.It should be noted the physician maintained continuous flush and used a rotating hemostasis valve (rhv).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: 6093638
• MDR Text Key: 59726963
• Report Number: 3005168196-2016-01584
• Device Sequence Number: 1
• Product Code: HCG
• UDI-Device Identifier: 00814548012834
• UDI-Public: 00814548012834
• 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: 10/12/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/10/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Physician
• Device Expiration Date: 10/15/2021
• Device Catalogue Number: RBY2C0320
• Device Lot Number: A39015
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/12/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/17/2013
• 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