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

Model Number	RBY2C1460-A
Medical Device Problem Codes	Failure to Advance (2524); Physical Resistance/Sticking (4012)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/07/2021
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: 1.3005168196-2021-02467.2.3005168196-2021-02469.
Event or Problem Description
The patient was undergoing a coil embolization procedure in the gastroduodenal artery (gda) using ruby coils, a non-penumbra microcatheter and sheath.During the procedure, the physician successfully placed six ruby coils in the target vessel using the microcatheter.While advancing the seventh ruby coil approximately five to ten centimeters into the hub of the microcatheter, the physician experienced resistance and subsequently the ruby coil became stuck.Therefore, the ruby coil was re-sheathed and saved.Next, the physician flushed the microcatheter using a syringe and checked if there was an issue with the microcatheter by advancing a guidewire over the microcatheter.It was reported that the guidewire was easily advanced over the microcatheter.Therefore, the physician attempted to re-advance the previously re-sheathed ruby coil into the hub of the microcatheter; however, the same issue occurred.The physician experienced resistance and subsequently, the ruby coil became stuck in the hub.Therefore, the ruby coil was removed.Afterwards, the physician successfully placed five ruby coils in the target vessel using the microcatheter.While introducing the twelfth ruby coil into the microcatheter, the physician experienced resistance and subsequently, the physician removed the ruby coil.The physician then attempted to advance the ruby coil within its introducer sheath on the back table; however, the ruby coil was stuck within its introducer sheath.An attempt was made to advance the introducer sheath over the ruby coil, but the introducer sheath became stuck on the pusher assembly.Therefore, the ruby coil was no longer used in the procedure.Next, the physician successfully placed eight ruby coils into the target vessel using the microcatheter.While placing the twentieth ruby coil inside the aneurysm, approximately two to three centimeters of the ruby coil moved into the big venous outflow part behind the aneurysm.The physician then decided to retract the ruby coil; however, while retracting the ruby coil into the microcatheter, the ruby coil unintentionally detached.Therefore, the physician decided to use a snare device to retrieve the detached ruby coil.While pulling the detached ruby coil into the microcatheter using the snare device, the ruby coil stretched and unraveled.Subsequently, after the physician removed the microcatheter, it was noticed that the detached ruby coil slipped out of the microcatheter and was hanging out of the sheath.It was reported that the physician was able to successfully pull the detached ruby coil from the sheath and no part of the ruby coil was left in the patient.The physician then examined the perfusion of the aneurysm via contrast and determined that no additional coils were needed.The procedure ended at this point.A follow-up computed tomography scan (ct) revealed that a small filament of the ruby coil remained in the patient's arterial system.The precise location of the filament is unclear; however, no therapeutic consequences to patient health were observed.The patient is scheduled to have another ct scan for a later date.
Event or Problem Description
The patient was undergoing a coil embolization procedure in the gastroduodenal artery (gda) using ruby coils, a non-penumbra microcatheter and sheath.During the procedure, the physician successfully placed six ruby coils in the target vessel using the microcatheter.While advancing the seventh ruby coil approximately five to ten centimeters into the hub of the microcatheter, the physician experienced resistance and subsequently the ruby coil became stuck.Therefore, the ruby coil was re-sheathed and saved.Next, the physician flushed the microcatheter using a syringe and checked if there was an issue with the microcatheter by advancing a guidewire over the microcatheter.It was reported that the guidewire was easily advanced over the microcatheter.Therefore, the physician attempted to re-advance the previously re-sheathed ruby coil into the hub of the microcatheter; however, the same issue occurred.The physician experienced resistance and subsequently, the ruby coil became stuck in the hub.Therefore, the ruby coil was removed.Afterwards, the physician successfully placed five ruby coils in the target vessel using the microcatheter.While introducing the twelfth ruby coil into the microcatheter, the physician experienced resistance and subsequently, the physician removed the ruby coil.The physician then attempted to advance the ruby coil within its introducer sheath on the back table; however, the ruby coil was stuck within its introducer sheath.An attempt was made to advance the introducer sheath over the ruby coil, but the introducer sheath became stuck on the pusher assembly.Therefore, the ruby coil was no longer used in the procedure.Next, the physician successfully placed eight ruby coils into the target vessel using the microcatheter.While placing the twentieth ruby coil inside the aneurysm, approximately two to three centimeters of the ruby coil moved into the big venous outflow part behind the aneurysm.The physician then decided to retract the ruby coil; however, while retracting the ruby coil into the microcatheter, the ruby coil unintentionally detached.Therefore, the physician decided to use a snare device to retrieve the detached ruby coil.While pulling the detached ruby coil into the microcatheter using the snare device, the ruby coil stretched and unraveled.Subsequently, after the physician removed the microcatheter, it was noticed that the detached ruby coil slipped out of the microcatheter and was hanging out of the sheath.It was reported that the physician was able to successfully pull the detached ruby coil from the sheath and no part of the ruby coil was left in the patient.The physician then examined the perfusion of the aneurysm via contrast and determined that no additional coils were needed.The procedure ended at this point.A follow-up computed tomography scan (ct) revealed that a small filament of the ruby coil remained in the arteria gastrica sinistra.The patient was discharged home and is reported to have no pain.The physician has recommended some physical restrictions to the patient.The patient is scheduled to have weekly sonograms to monitor the position of the ruby coil filament.As of 21-dec-2021, no additional interventional procedure is scheduled.
Additional Manufacturer Narrative
Please note that the following section is being updated based on additional information provided by a penumbra sales representative on 12/20/2021: 1.Section b.Box 5.Describe event or problem.Evaluation of the returned ruby coil revealed that the introducer sheath was ovalized.If the device is forcefully mishandled during use, damage such as this may occur.This damage likely contributed to the resistance experienced during the procedure.Forceful advancement against this resistance likely contributed to the offset coil winds on the embolization coil.Further evaluation of the device revealed kinks through out the length of the introducer sheath and the embolization coil was stuck within the introducer sheath friction lock.This damage was likely incidental to the complaint.Evaluation of the returned ruby coil revealed offset coil winds.If the device is forcefully manipulated against resistance, damage such as offset coil winds may occur.The root cause of the resistance could not be determined.During functional testing, the ruby coil was able to advance through its introducer sheath and a demonstration lantern with resistance due to the offset coil winds.Further evaluation of the device revealed pusher assembly kink.This damage was likely incidental to the complaint and may have occurred during packaging for the return.Penumbra coils are inspected during in-process inspection and during quality inspection after manufacturing.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: 1.3005168196-2021-02467 2.3005168196-2021-02469.

• Brand Name: RUBY COIL
• Common Device Name: HCG, KRD
• Manufacturer (Section D): PENUMBRA, INC.; one penumbra place; alameda CA 94502
• Manufacturer Contact: veronica farris ; one penumbra place; alameda, CA 94502 ; 5107483200
• MDR Report Key: 12741601
• Report Number: 3005168196-2021-02468
• Device Sequence Number: 4479796
• Product Code: HCG
• UDI-Device Identifier: 00814548013046
• UDI-Public: 00814548013046
• Combination Product (Y/N): Y
• Initial Reporter Country: GM
• PMA/510(K) Number: K120330
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 01/18/2022
• Report Date (Section F): 01/01/2005

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: Health Professional
• Device Model Number: RBY2C1460-A
• Device Catalogue Number: RBY2C1460
• Device Lot Number: F92990
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/14/2021
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report to Manufacturer: 01/10/2005
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/07/2021
• Supplement Date Received by Manufacturer: 12/20/2021
• Initial Report FDA Received Date: 11/02/2021
• Supplement Report FDA Received Date: 01/18/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/09/2019
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Age: 58 YR
• Patient Sex: Male
• Patient Weight: 75 KG
• Date Report Sent to FDA: 01/01/2005