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

Catalog Number	RBY4C0415
Medical Device Problem Codes	Physical Resistance (2578); Difficult to Advance (2920)
Health Effect - Clinical Code	Thrombus (2101)
Date of Event	06/01/2017
Type of Reportable Event	Serious Injury
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: 3005168196-2017-01049.3005168196-2017-01050.3005168196-2017-01051.3005168196-2017-01052.3005168196-2017-01054.3005168196-2017-01055.3005168196-2017-01056.The device was discarded by the hospital.
Event or Problem Description
The patient was undergoing a coil embolization procedure in the splenic artery using ruby coils.During the procedure, the physician placed a diagnostic catheter in the target vessel then advanced a lantern delivery microcatheter (lantern) through the catheter.While attempting to advance a ruby coil through the lantern, the physician experienced immediate resistance after the first centimeter of the coil was out of the tip the lantern; therefore, the ruby coil was removed.The physician then removed the lantern and advanced the sheath and base catheter more distal to help alleviate some of the tortuosity.The physician then placed a new lantern in the target vessel and successfully deployed and detached three ruby coils in the target vessel.While attempting to advance a new ruby coil out of its introducer sheath and into the lantern, the scrub technologist experienced resistance.It was also reported that resistance was encountered immediately after advancing the ruby coil into the hub of the lantern; therefore, the ruby coil was removed.After that, the physician attempted to advance a new ruby coil through the lantern; however, resistance was encountered again.Therefore, the physician removed the ruby coil and noted thrombus in the lantern as well as in the diagnostic catheter.A new flush line was then hung and the lantern was flushed.Thereafter, the physician reloaded the previously removed ruby coil into the lantern; however, resistance was encountered after advancing about the first centimeter of the ruby coil out of the lantern.Therefore, the ruby coil was removed.While attempting to advance a new ruby coil through the lantern, resistance was encountered when part of the coil was out of the lantern.Therefore, the ruby coil was successfully removed.Next, the physician attempted to advance a new ruby coil through the same lantern; however, resistance was encountered after advancing about half of the ruby coil into the aneurysm.Therefore, the ruby coil was withdrawn.Again the physician noted thrombus in the base catheter and felt the aneurysm was thrombosing.The procedure was ended at this point and the physician flushed everything really well.No heparin was given to the patient.In addition, there was no alleged malfunction against the first lantern.The physician just wanted to switch to a new lantern because of the tortuosity and length of procedure.It should also be noted that there was no alleged malfunction against the second lantern.

• Brand Name: RUBY COIL
• Common Device Name: HCG, KRD
• Manufacturer (Section D): PENUMBRA, INC.; one penumbra place; alameda CA 94502
• MDR Report Key: 6682398
• Report Number: 3005168196-2017-01053
• Device Sequence Number: 1615635
• Product Code: HCG
• UDI-Device Identifier: 00814548013176
• UDI-Public: 00814548013176
• Combination Product (Y/N): N
• Initial Reporter State: MN
• 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): 06/01/2017

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: 02/19/2025
• Device Catalogue Number: RBY4C0415
• Device Lot Number: F74515
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/01/2017
• Initial Report FDA Received Date: 06/30/2017
• 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: Other; Required Intervention
• Patient Age: 60 YR