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

Catalog Number	RBY4C0630
Medical Device Problem Codes	Detachment Of Device Component (1104); Retraction Problem (1536); Device Operates Differently Than Expected (2913)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	02/01/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
This device is available for return.A follow up mdr will be submitted upon completion of the device investigation.This report is associated with mfr report numbers: 3005168196-2018-00429, 3005168196-2018-00430.
Event or Problem Description
The patient was undergoing a coil embolization procedure in the renal artery using ruby coils.During the procedure, the physician successfully placed three ruby coils in the target location using a lantern delivery microcatheter (lantern).While advancing a fourth ruby coil (f66607) into the lantern, the physician experienced resistance; therefore, the ruby coil was removed and not used.The physician then successfully placed multiple ruby coils in the target location.Next, the physician advanced another ruby coil (f72714) through the lantern but subsequently removed the ruby coil, in order to reposition the lantern.This ruby coil was rinsed in saline after being removed but detached outside of the patient as the physician attempted to retract it into its introducer sheath.The physician, therefore, continued the procedure and successfully placed multiple ruby coils in the target location.The physician then attempted to advance one last ruby coil (f68921), however, the ruby coil kept kicking out of the aneurysm as it was being advanced.It was reported that the aneurysm was densely packed at this point.Upon attempting to retract the ruby coil from the lantern, it unintentionally detached within the lantern.The lantern was therefore removed with the detached ruby coil inside.The procedure ended at this point because the target location was successfully embolized.There was no report of an adverse effect to the patient.
Additional Manufacturer Narrative
The device was initially available for return; however, additional information obtained on 12 april 2018 indicated that the device was no longer available fro return; therefore, the report was updated accordingly.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 numbers: 3005168196-2018-00429, 3005168196-2018-00430.The hospital disposed of the device.

• Brand Name: RUBY COIL
• Common Device Name: HCG, KRD
• Manufacturer (Section D): PENUMBRA, INC.; one penumbra place; alameda CA 94502
• MDR Report Key: 7300045
• Report Number: 3005168196-2018-00431
• Device Sequence Number: 1823467
• Product Code: HCG
• UDI-Device Identifier: 00814548013190
• UDI-Public: 00814548013190
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: K120330
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 02/01/2018

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: 04/12/2024
• Device Catalogue Number: RBY4C0630
• Device Lot Number: F68921
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 02/01/2018
• Supplement Date Received by Manufacturer: 04/12/2018
• Initial Report FDA Received Date: 02/27/2018
• Supplement Report FDA Received Date: 04/12/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 51 YR