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

Catalog Number	RBY2C1240
Medical Device Problem Codes	Physical Resistance (2578); Mechanical Jam (2983)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	03/20/2018
Type of Reportable Event	Malfunction
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: 3005168196-2018-00758, 3005168196-2018-00759.The hospital disposed of the device.
Event or Problem Description
The patient was undergoing a coil embolization procedure in the portal vein using ruby coils.During the procedure, the physician experienced while advancing a ruby coil through a non-penumbra microcatheter and the ruby coil became stuck.The physician then reposition the microcatheter, and attempted to advance the ruby coil; however, was still unable to advance the ruby coil, therefore it was removed.Next, the physician attempted to advance a new ruby coil, however the same resistance was experienced and the ruby coil became stuck.While retracting to remove the ruby coil, it unintentionally detached from the pusher assembly.The physician therefore removed the microcatheter with the detached ruby coil inside.The physician then placed a new non-penumbra microcatheter and attempted to place another ruby coil, however resistance was experienced again despite attempts to reposition the microcatheter.The ruby coil and microcatheter were removed and the procedure was completed using a lantern delivery microcatheter (lantern) and additional ruby coils.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: 7437113
• Report Number: 3005168196-2018-00760
• Device Sequence Number: 334413
• Product Code: HCG
• UDI-Device Identifier: 00814548013015
• UDI-Public: 00814548013015
• 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
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 03/20/2018

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
• Operator of Device: Physician
• Device Expiration Date: 05/10/2025
• Device Catalogue Number: RBY2C1240
• Device Lot Number: F77074
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/20/2018
• Initial Report FDA Received Date: 04/17/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 61