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

Model Number	RBYLP0406
Medical Device Problem Code	Separation Failure (2547)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/05/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device has been returned and the investigation results are pending.A follow up mdr will be submitted upon completion of the device investigation.This report is associated with mfr report numbers: 3005168196-2021-01933, 3005168196-2021-01935, 3005168196-2021-01936, 3005168196-2021-01937, 3005168196-2021-01938.
Event or Problem Description
The patient was undergoing a coil embolization procedure in the superior mesenteric artery (sma) to treat a type ii endoleak using ruby coil lps, lp system detachment handles (handles), and a non-penumbra microcatheter.It was noted that the patient anatomy was tortuous.During the procedure, while attempting to place the ruby coil lp into the aneurysm, the ruby coil lp kicked the microcatheter out of the target vessel due to the ruby coil lp being big for the size of the aneurysm.Therefore, the physician decided to remove the ruby coil lp.While attempting to retract and recapture the ruby coil lp, the physician kinked the pusher assembly of the ruby coil lp at multiple locations.It was reported that the physician experienced resistance while advancing and retracting the ruby coil lp due to the tortuous anatomy of the patient.Next, the physician advanced a smaller ruby coil lp into the target vessel and attempted to detach it using a handle; however, the ruby coil lp failed to detach.The physician then made additional attempts to detach the ruby coil lp using a new handle and by manually detaching it but were unsuccessful.Therefore, the ruby coil lp was removed.Subsequently, same issue occurred with the next ruby coil lp that was advanced into the target vessel.The ruby coil lp failed to detach using the same two handles and by manually detaching it.Therefore, the ruby coil lp was removed.The physician then advanced another ruby coil lp into the target vessel and attempted to detach it using both handles; however, the ruby coil lp failed to detach.Therefore, the physician decided to retract the ruby coil lp.While retracting the ruby coil lp, the ruby coil lp unintentionally detached halfway in the microcatheter.The physician then flushed the detached ruby coil lp out of the microcatheter and into the target location using a 3cc syringe and subsequently, the ruby coil lp was implanted successfully.Afterwards, the physician tried placing one of the previously removed ruby coil lps; however, the same issue occurred.The ruby coil lp failed to detach; therefore, the ruby coil lp was removed.The physician decided to end the procedure at this point with only one ruby coil lp implanted.There was no report of an adverse effect to the patient.
Additional Manufacturer Narrative
Evaluation of the first returned ruby coil lp confirmed that the embolization coil was not detached from the pusher assembly.Further evaluation revealed that the pet lock was separated, and the pull wire was not present on the proximal end of the pusher assembly.This damage was incidental to the reported complaint and likely occur during the attempt to detach the embolization coil.Further evaluation also revealed that the pusher assembly had bends within its length, and the pull wire was within the ddt.This damage was incidental to the reported complaint.The bends within the pusher assembly may have occurred due to the patient anatomy.Based on the returned condition, the root cause of the detachment issue could not be determined.Evaluation of the second returned ruby coil lp confirmed that the embolization coil was not detached from the pusher assembly.Further evaluation revealed that the pet lock was separated, and the pull wire was not present on the proximal end of the pusher assembly.This damage was incidental to the reported complaint and likely occur during the attempt to detach the embolization coil.Further evaluation also revealed that the pusher assembly had kinks throughout its length.This damage was incidental to the reported complaint and the root cause could not be determined.Based on the returned condition, the root cause of the detachment issue could not be determined.Penumbra coils 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: 3005168196-2021-01933, 3005168196-2021-01935, 3005168196-2021-01936, 3005168196-2021-01937, 3005168196-2021-01938.

• Brand Name: RUBY COIL LP
• Common Device Name: HCG, KRD
• Manufacturer (Section D): PENUMBRA, INC.; one penumbra place; alameda CA 94502
• MDR Report Key: 12402562
• Report Number: 3005168196-2021-01934
• Device Sequence Number: 14767604
• Product Code: HCG
• UDI-Device Identifier: 00815948021808
• UDI-Public: 00815948021808
• Combination Product (Y/N): Y
• Initial Reporter State: ND
• Initial Reporter Country: US
• PMA/510(K) Number: K192955
• 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): 09/22/2021
• 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 Expiration Date: 02/08/2025
• Device Model Number: RBYLP0406
• Device Catalogue Number: RBYLP0406
• Device Lot Number: F96162
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/25/2021
• Was the Report Sent to FDA?: Yes
• Date Report to Manufacturer: 01/10/2005
• Initial Date Received by Manufacturer: 08/05/2021
• Supplement Date Received by Manufacturer: 09/09/2021
• Initial Report FDA Received Date: 08/31/2021
• Supplement Report FDA Received Date: 09/22/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 60 YR
• Date Report Sent to FDA: 01/01/2005