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

Model Number	RBY2C0410-B
Medical Device Problem Codes	Failure to Fold (1255); Difficult to Remove (1528); Physical Resistance/Sticking (4012)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/19/2021
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: 3005168196-2021-00543.
Event or Problem Description
The patient was undergoing a coil embolization procedure in the splenic artery using pod coils, ruby coils, and a lantern delivery microcatheter (lantern).It should be noted that the target anatomy was tortuous.During the procedure, the physician experienced sizing issues with other penumbra coils; therefore, these coils were not implanted and were removed from the procedure.While implanting the first pod coil, it would not form in the vessel.The physician decided to remove the pod coil and, while retracting the coil back into the microcatheter, resistance was encountered.After removing the pod coil, the physician attempted to implant a ruby coil and reported that the coil also did not form in the vessel.It was reported that the physician experienced resistance while advancing and retracting the ruby coil.The physician was unable to retract the ruby coil back into the microcatheter at first, but eventually did and subsequently removed the ruby coil from the procedure.The procedure continued with other penumbra coils; however, the physician experienced sizing issues with these coils.Therefore, the penumbra coils with sizing issues were not implanted and were removed from the procedure.The procedure was completed using the same lantern and a ruby coil.Post-procedure, the physician reported that a vessel dissection had occurred.The direct cause of the vessel dissection was not determined but was thought to be associated with either the pod coil pusher wire or inability to heparinize the patient.There was no reported action taken to treat the vessel dissection; however, it reportedly healed on its own.The patient was in stable condition when the imaging was being reviewed.The patient's current condition is unknown.
Additional Manufacturer Narrative
Please note that the following section is being updated based on additional information provided by the sales representative on 04/05/2021: this report is associated with mfr report number: 3005168196-2021-00543.
Event or Problem Description
The patient was undergoing a coil embolization procedure in the splenic artery using pod coils, ruby coils, and a lantern delivery microcatheter (lantern).It should be noted that the target anatomy was tortuous.During the procedure, the physician experienced sizing issues with other penumbra coils; therefore, these coils were not implanted and were removed from the procedure.While implanting the first pod coil, it would not form in the vessel.The physician decided to remove the pod coil and, while retracting the coil back into the microcatheter, resistance was encountered.After removing the pod coil, the physician attempted to implant a ruby coil and reported that the coil also did not form in the vessel.It was reported that the physician experienced resistance while advancing and retracting the ruby coil.The physician was unable to retract the ruby coil back into the microcatheter at first, but eventually did and subsequently removed the ruby coil from the procedure.The procedure continued with other penumbra coils; however, the physician experienced sizing issues with these coils.Therefore, the penumbra coils with sizing issues were not implanted and were removed from the procedure.The procedure was completed using the same lantern and a ruby coil.Post-procedure, the physician reported that a vessel dissection had occurred.The direct cause of the vessel dissection was not determined but was thought to be associated with either the pod coil pusher wire or inability to heparinize the patient.There was no reported action taken to treat the vessel dissection; however, it reportedly healed on its own.The patient was in stable condition when the imaging was being reviewed.The patient's current condition is stable.

• Brand Name: RUBY COIL
• Common Device Name: HCG, KRD
• Manufacturer (Section D): PENUMBRA, INC.; one penumbra place; alameda CA 94502
• MDR Report Key: 11531996
• Report Number: 3005168196-2021-00544
• Device Sequence Number: 3764747
• Product Code: HCG
• UDI-Device Identifier: 00814548018577
• UDI-Public: 00814548018577
• Combination Product (Y/N): Y
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K173614
• 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,Followup
• Report Date (Section B): 02/19/2021
• 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: RBY2C0410-B
• Device Catalogue Number: RBY2C0410
• Device Lot Number: F99004
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Date Report to Manufacturer: 01/10/2005
• Initial Date Received by Manufacturer: 02/19/2021
• Supplement Date Received by Manufacturer: 04/05/2021
• Initial Report FDA Received Date: 03/19/2021
• Supplement Report FDA Received Date: 05/11/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Date Report Sent to FDA: 01/01/2005