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

Model Number	RBY4C0860-B
Medical Device Problem Code	Premature Separation (4045)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/19/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Evaluation of the returned ruby coil revealed that the embolization coil was detached from its pusher assembly, and the complaint was confirmed.Evaluation revealed that the sr component was fractured.The sr component fracture is likely the cause of the embolization coil detaching from its pusher assembly.If the ruby coil is manipulated against resistance during use, damage such as a sr component fracture may occur.Further evaluation revealed that the embolization coil was unraveled.This damage was incidental to the reported complaint and likely resulted from the sr wire fracture and snaring of embolization coil during removal.Penumbra products 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.
Event or Problem Description
The patient was undergoing a coil embolization procedure in the gonadal vein using ruby coils, pod coils, a non-penumbra microcatheter, and a diagnostic catheter.It was reported that access to the target vessel was challenging and long.During the procedure, while attempting to advance a pod coil to the target vessel using the microcatheter and diagnostic catheter, the microcatheter and diagnostic catheter kept kicking out due to the challenging access.Therefore, the pod coil was removed.Subsequently, the same issue occurred with a second pod coil.Therefore, the pod coil was also removed.Next, while advancing a ruby coil to the target vessel, the ruby coil unintentionally detached partially in the microcatheter and partially in the target vessel.It was reported that an attempt was made to push the detached ruby coil into the target location using the pusher assembly; however, it was unsuccessful.Therefore, the physician used a snare device to remove the detached ruby coil.The procedure ended at this point due to radiation exposure because access was challenging and long, and the physician planned to bring the patient back in on a later date.There was no report of an adverse effect to the patient.

• 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: 12792067
• Report Number: 3005168196-2021-02544
• Device Sequence Number: 5644587
• Product Code: HCG
• UDI-Device Identifier: 00814548018393
• UDI-Public: 00814548018393
• Combination Product (Y/N): N
• Initial Reporter State: MA
• Initial Reporter Country: US
• PMA/510(K) Number: K173614
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 11/10/2021
• 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?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: RBY4C0860-B
• Device Catalogue Number: RBY4C0860
• Device Lot Number: F100274
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/25/2021
• 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: 10/19/2021
• Initial Report FDA Received Date: 11/11/2021
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/15/2020
• 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
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 44 YR
• Patient Sex: Male
• Patient Weight: 200 KG
• Date Report Sent to FDA: 01/01/2005