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

Catalog Number	RBY2C0415
Medical Device Problem Codes	Detachment Of Device Component (1104); Unraveled Material (1664)
Health Effect - Clinical Code	Device Embedded In Tissue or Plaque (3165)
Date of Event	10/12/2016
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The device has been returned and the investigation results are pending.A follow up mdr will be submitted upon completion of the device investigation.The manufacturing records for this lot were reviewed and did not reveal any outstanding discrepancies, design, or quality concerns.The device is implanted in the patient.
Event or Problem Description
The patient was undergoing coil embolization procedure treating an actively bleeding duodenal mass using ruby coils.During the procedure, the physician successfully embolized the gastroduodenal artery (gda) using ruby coils and non-penumbra coils with no incident.Thereafter, the physician began embolizing the inferior pancreaticoduodenal artery (ipda) by successfully implanting a non-penumbra coil in the target vessel.The physician then attempted to advance a ruby coil in the ipda; however, while advancing the ruby coil through a non-penumbra microcatheter, the physician felt a loss of resistance and noticed that the ruby coil had unintentionally detached.The physician initially attempted to deliver the ruby coil in the target vessel by pushing it out of the microcatheter with the pusher assembly; however, the ruby coil flew into the aorta due to high blood flow.Therefore, the physician used a snare device to retrieve the ruby coil.However, upon removing the ruby coil using the snare, the physician noticed that the ruby coil had unraveled and part of it was still within the patient.While pulling a strand of this unravel ruby coil in order to remove it from the patient, the strand broke.An angiogram revealed that a portion of the unravel coil was still outside of the patient ipda; however, the physician decided to leave unravel ruby coil portion in the patient for fear of it unraveling further.The physician believes that the portion of unravel ruby coil could not cause an adverse effect to the patient and the procedure was stopped at that point.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: 6087646
• Report Number: 3005168196-2016-01580
• Device Sequence Number: 1602561
• Product Code: HCG
• UDI-Device Identifier: 00814548012858
• UDI-Public: 00814548012858
• Combination Product (Y/N): N
• Initial Reporter State: NY
• 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: Physician
• Type of Report: Initial
• Report Date (Section B): 10/12/2016

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: 11/09/2023
• Device Catalogue Number: RBY2C0415
• Device Lot Number: F66430
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/12/2016
• Initial Report FDA Received Date: 11/08/2016
• 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
• Patient Age: 68 YR