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

Catalog Number	RBY2C0430
Medical Device Problem Codes	Kinked (1339); Device Damaged Prior to Use (2284); Out-Of-Box Failure (2311)
Health Effect - Clinical Code	No Patient Involvement (2645)
Date of Event	01/30/2017
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 numbers: 3005168196-2017-00259, 3005168196-2017-00260, 3005168196-2017-00261, 3005168196-2017-00263, 3005168196-2017-00264, 3005168196-2017-00265.The hospital disposed of the device.
Event or Problem Description
The patient was undergoing a coil embolization procedure in the splenic artery using ruby coils, pod packing coils (podj) and lantern delivery microcatheters (lanterns).During the procedure, the physician successfully placed a 135cm lantern (f69982) through a non-penumbra sheath, and advanced a ruby coil (f64580) through it.The physician then attempted to detach the ruby coil using a ruby coil detachment handle (handle); however, the ruby coil was unable to be detached.The physician then attempted to use a new handle to detach this ruby coil and the new handle failed to detach the ruby coil as well; therefore, the physician manually detached the ruby coil.Both handles were able to successfully detach other ruby coils later in the procedure.Next, the physician attempted to advance a new ruby coil (f62420) through the lantern; however, resistance was experienced and the ruby coil became stuck and unable to advance out of the tip of the lantern.The physician then removed the ruby coil; however, upon removal, the physician inadvertently bent the ruby coil pusher assembly.Upon attempting to advance a new ruby coil through the same lantern, the physician noticed that ruby coil became stuck and unable to advance as well; therefore, the ruby coil and the lantern were removed.The physician then exchanged the lantern for a new 150cm lantern (f70527) and attempted to advance the same ruby coil; however, the ruby coil was only able to advance a little further but still unable to exit the lantern; therefore, the ruby coil was removed again.The physician then decided to exchange the lantern for a larger non-penumbra microcatheter and successfully deployed and detached the ruby coil, as well as numerous additional ruby coils.Around the end of the procedure, the physician experienced resistance while advancing a podj through the same non-penumbra microcatheter and inadvertently kinked the podj pusher assembly.Therefore, the podj was removed and the physician attempted to advance a ruby coil (f71658) through the microcatheter.However, resistance was experienced again and the ruby coil became stuck and unable to advance out of the non-penumbra microcatheter.While removing this ruby coil from the microcatheter; the physician inadvertently kinked its pusher assembly.The physician then noticed that the microcatheter was clotted, and upon clearing the microcatheter and subsequent imaging, the physician found that no further coils were needed; therefore, the procedure ended at this point.During the procedure, an additional ruby coil (f64581) was inadvertently kinked by the physician upon removal from the protective hoop and, therefore, it was not used in the patient.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: 6368387
• Report Number: 3005168196-2017-00262
• Device Sequence Number: 1081524
• Product Code: HCG
• UDI-Device Identifier: 00814548012872
• UDI-Public: 00814548012872
• Combination Product (Y/N): N
• Initial Reporter State: WI
• 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: Radiologic Technologist
• Type of Report: Initial
• Report Date (Section B): 01/30/2017

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: 06/23/2023
• Device Catalogue Number: RBY2C0430
• Device Lot Number: F64581
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/30/2017
• Initial Report FDA Received Date: 03/01/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1