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

Catalog Number	RBY2C0410-A
Medical Device Problem Code	Detachment Of Device Component (1104)
Health Effect - Clinical Codes	No Consequences Or Impact To Patient (2199); Device Embedded In Tissue or Plaque (3165)
Date of Event	08/23/2016
Type of Reportable Event	Serious Injury
Additional 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.This report is associated with mfr report number: 3005168196-2016-01359.The device is implanted in the patient.
Event or Problem Description
The patient was undergoing a coil embolization in the bronchial artery using ruby coils.During the procedure, while advancing and deploying a ruby coil through a lantern delivery microcatheter (lantern), the physician decided to retract the ruby coil in order to reposition it.However, while retracting the ruby coil, the physician noticed the ruby coil had unintentionally detached from the pusher assembly inside the patient's body.The physician attempted to remove the coil from the patient's body using a snare device but was unsuccessful.The ruby coil was left in the patient's body, proximal to the aneurysm.Next,the physician advanced and deployed a new ruby coil in the target vessel using the lantern.However, while attempting to retract the ruby coil in order to reposition it, the physician noticed the ruby coil had unintentionally detached.Part of the detached ruby coil was already inside the aneurysm except the tail.The physician then attempted to snare it but was unsuccessful; therefore the detached ruby coil was left in the patient.Thereafter, the procedure was completed using non-penumbra coils and the same lantern.The physician maintained continuous flush through the rotating hemostasis valve (rhv) in this procedure.There was no report of an adverse effect to the patient.

• Brand Name: RUBY COIL
• Common Device Name: HCG, KRD
• Manufacturer (Section D): PENUMBRA, INC.; one penumbra place; alameda CA 94502
• MDR Report Key: 5963679
• Report Number: 3005168196-2016-01358
• Device Sequence Number: 19042564
• Product Code: HCG
• UDI-Device Identifier: 00814548012841
• UDI-Public: 00814548012841
• Combination Product (Y/N): N
• Initial Reporter State: NV
• Initial Reporter Country: US
• PMA/510(K) Number: K120330
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2016
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 08/24/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Physician
• Device Expiration Date: 05/30/2024
• Device Catalogue Number: RBY2C0410-A
• Device Lot Number: F69580
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/24/2016
• Initial Report FDA Received Date: 09/20/2016
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention