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

Model Number	RBY2C1260-B
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	07/26/2021
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: 3005168196-2021-01874, 3005168196-2021-01876.
Event or Problem Description
The patient was undergoing a coil embolization procedure in the short gastric artery using ruby coils, a lantern delivery microcatheter (lantern), non-penumbra coils, and a non-penumbra catheter.During the procedure, the physician placed a ruby coil and two non-penumbra coils into the target location using the lantern.While advancing the next ruby coil through the lantern, the physician experienced resistance.Subsequently, the ruby coil became stuck in the middle of the lantern; therefore, the ruby coil was removed.Next, while advancing another ruby coil through the lantern, the same issue occurred.The physician experienced resistance and subsequently, the ruby coil became stuck in the middle of the lantern.Therefore, the ruby coil and the lantern were removed.The procedure was completed using four pod packing coils (pod pcs) and a new lantern.There was no report of an adverse effect to the patient.
Event or Problem Description
The patient was undergoing a coil embolization procedure in the short gastric artery using ruby coils, a lantern delivery microcatheter (lantern), non-penumbra coils, and a non-penumbra catheter.During the procedure, the physician placed a ruby coil and two non-penumbra coils into the target location using the lantern.While advancing the next ruby coil it became stuck in front of the target lesion and was detached there.Next, the physician advanced another ruby coil in an attempt to push the previous ruby coil into the target location.However, the physician experienced resistance and the ruby coil became stuck in the middle of the lantern.Therefore, the physician decided to remove the ruby coil and the lantern.While retrieving the lantern and ruby coil, the previously detached ruby coil was inadvertently removed.The procedure was completed using four pod packing coils (pod pcs) and a new lantern.There was no report of an adverse effect to the patient.
Additional Manufacturer Narrative
Please note that the following section is being updated based on additional information provided by a penumbra distributor on 09/02/2021: 1.Section b.Box 5.Describe event or problem evaluation of the first returned ruby coil revealed that the pusher assembly was fractured, the pull wire was retracted out of the distal fractured segment.If the ruby coil is advanced against resistance, damage such as a kink may occur.Further manipulation of a kinked device may worsen to a fracture.If the two fractured segments are separated and the pull wire is retracted out of the ddt, the embolization coil will detach from its pusher assembly.The root cause of resistance could not be determined.Further evaluation revealed kinks in the pusher assembly.This damage was incidental to the reported complaint and the root cause could not be determined.Evaluation of the second returned ruby coil revealed offset coil winds on the embolization coil inside the introducer sheath and the pusher assembly kinks.This damage was incidental to the reported complaint and the root cause could not be determined.During the functional test, resistance was encountered while attempting to re-sheath the embolization coil, and the ruby coil could not be re-sheathed.Therefore, no further functional testing was performed.Evaluation of the returned lantern revealed that the catheter was kinked and ovalized.This damage was incidental to the reported complaint and the root cause of this damage could not be determined.During the functional test, a demonstration coil was advanced through the lantern without an issue.Penumbra devices are visually 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: 1.3005168196-2021-01874, 2.3005168196-2021-01876.H3 other text : placeholder.

• Brand Name: RUBY COIL
• Common Device Name: HCG, KRD
• Manufacturer (Section D): PENUMBRA, INC.; one penumbra place; alameda CA 94502
• MDR Report Key: 12356187
• Report Number: 3005168196-2021-01875
• Device Sequence Number: 4535842
• Product Code: HCG
• UDI-Device Identifier: 00814548019093
• UDI-Public: 00814548019093
• Combination Product (Y/N): Y
• Initial Reporter Country: JA
• PMA/510(K) Number: K173614
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: distributor,foreign,health pr
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 09/30/2021
• 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: RBY2C1260-B
• Device Catalogue Number: RBY2C1260
• Device Lot Number: F106557
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/18/2021
• Was the Report Sent to FDA?: Yes
• Date Report to Manufacturer: 01/10/2005
• Initial Date Received by Manufacturer: 07/28/2021
• Supplement Date Received by Manufacturer: 08/31/2021
• Initial Report FDA Received Date: 08/23/2021
• Supplement Report FDA Received Date: 10/01/2021
• 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