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

Model Number	RBY4C0860-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	09/02/2021
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 numbers: 3005168196-2021-02116, 3005168196-2021-02117.
Event or Problem Description
The patient was undergoing a coil embolization procedure in the splenic artery using pod packing coils (pod pcs), ruby coils, non-penumbra sheath, non-penumbra catheter, a non-penumbra microcatheter and a guidewire.During the procedure, the physician successfully implanted approximately twenty five penumbra coils in the target location.While attempting to advance the next two pod pcs and one ruby coil through the microcatheter, the physician encountered resistance and the coils would not advance fully and only half of the coils would enter the microcatheter.Therefore, the three coils were removed.It was reported that the microcatheter was flushed before the coils were introduced.The physician then used a guidewire in order to clear the microcatheter and was subsequently able to deliver multiple coils using the same microcatheter.The procedure was completed using additional penumbra coils and the same microcatheter.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: 12521956
• Report Number: 3005168196-2021-02118
• Device Sequence Number: 11788023
• Product Code: HCG
• UDI-Device Identifier: 00814548018393
• UDI-Public: 00814548018393
• Combination Product (Y/N): Y
• Initial Reporter State: MI
• 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): 09/23/2021
• 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: RBY4C0860-B
• Device Catalogue Number: RBY4C0860
• Device Lot Number: F99802
• 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: 09/02/2021
• Initial Report FDA Received Date: 09/23/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 16 YR
• Date Report Sent to FDA: 01/01/2005