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

Catalog Number	RBY2C0312
Medical Device Problem Codes	Bent (1059); Failure to Advance (2524)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	05/25/2017
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: 3005168196-2017-00978.
Event or Problem Description
The patient was undergoing coil embolization procedure in the gastroduodenal artery (gda) using ruby coils.During the procedure, the physician successfully deployed and detached initial ruby coils into the target vessel using a non-penumbra microcatheter.While advancing a new ruby coil through the microcatheter, the physician did not mention any resistance; however, the coil unintentionally detached while partially inside the vessel.Therefore, the physician used a snare device to remove the detached ruby coil.Next, while attempting to advance a new ruby coil through the microcatheter, the physician did not mention any resistance; however, the coil was unable to completely advance out of the tip of the microcatheter.Therefore, the ruby coil was removed and it was noted that the pusher assembly appeared to be bent.The procedure was then successfully completed using additional coils and a lantern delivery microcatheter (lantern).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: 6663401
• Report Number: 3005168196-2017-00979
• Device Sequence Number: 1882692
• Product Code: HCG
• UDI-Device Identifier: 00814548012827
• UDI-Public: 00814548012827
• Combination Product (Y/N): N
• Initial Reporter State: OR
• 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): 05/25/2017

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
• Operator of Device: Physician
• Device Expiration Date: 01/07/2025
• Device Catalogue Number: RBY2C0312
• Device Lot Number: F73587
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/25/2017
• Initial Report FDA Received Date: 06/23/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 66 YR