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

Model Number	RBY2C4060-B
Medical Device Problem Code	Failure to Fold (1255)
Health Effect - Clinical Codes	No Consequences Or Impact To Patient (2199); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/30/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The product was not returned for evaluation.Without the return of the device, an investigation cannot be performed.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: 3005168196-2021-00160.
Event or Problem Description
The patient was undergoing a coil embolization procedure in the right hypogastric artery using ruby coils and pod packing coils (pod pcs).During the procedure, it was reported that a ruby coil would not take shape in the target vessel and would run down the visceral vessel.Therefore, the ruby coil was removed.Next, a pod pc pusher wire became bent upon removal from its packaging hoop.Therefore, the pod pc was not used in the procedure.It was also reported that another pod pc was unable to fit in the coil pack; therefore, the pod pc was removed from the patient.While attempting to advance another pod pc into the target location, the coil detached outside of the microcatheter (unknown).Therefore, the microcatheter and the pod pc were removed together from the patient and the pod pc was retrieved.The procedure was completed using additional ruby coils.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
• MDR Report Key: 11227154
• Report Number: 3005168196-2021-00159
• Device Sequence Number: 11691886
• Product Code: HCG
• UDI-Device Identifier: 00814548019437
• UDI-Public: 00814548019437
• Combination Product (Y/N): Y
• Initial Reporter State: IL
• 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
• Report Date (Section B): 12/30/2020
• 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: RBY2C4060-B
• Device Catalogue Number: RBY2C4060
• Device Lot Number: F88858
• Was Device Available for Evaluation?: No
• 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: 12/30/2020
• Initial Report FDA Received Date: 01/25/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 70 YR
• Date Report Sent to FDA: 01/01/2005