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

Model Number	RBY2C0530-A
Medical Device Problem Codes	Physical Resistance/Sticking (4012); Premature Separation (4045)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	10/25/2019
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.This report is associated with mfr report number: 3005168196-2019-02167.
Event or Problem Description
The patient was undergoing a coil embolization procedure in the splenic artery using ruby coils and a lantern delivery microcatheter (lantern).It was reported that the patient's anatomy was very torturous.During the procedure, while advancing the lantern and a non-penumbra catheter though a sheath in the target vessel, the lantern would not track, and the physician experienced resistance; therefore, the lantern was removed.Subsequently, another microcatheter was advanced through the same catheter and sheath.Next, while advancing a ruby coil through the microcatheter, the physician experienced resistance.The physician then decided to withdraw the ruby coil, and upon withdrawal, it unintentionally detached inside the microcatheter; therefore, the microcatheter containing the detached ruby coil was removed, and the ruby coil flushed out.The procedure was completed using other ruby coils and the same microcatheter, catheter, and sheath.There was no report of an adverse effect to the patient.
Additional Manufacturer Narrative
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: 1.3005168196-2019-02167.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: 9366156
• Report Number: 3005168196-2019-02166
• Device Sequence Number: 2626590
• Product Code: HCG
• UDI-Device Identifier: 00814548012919
• UDI-Public: 00814548012919
• Combination Product (Y/N): Y
• Initial Reporter State: NJ
• Initial Reporter Country: US
• PMA/510(K) Number: K120330
• 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): 10/25/2019
• 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: 10/31/2022
• Device Model Number: RBY2C0530-A
• Device Catalogue Number: RBY2C0530
• Device Lot Number: F60941
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Date Report to Manufacturer: 01/10/2005
• Initial Date Received by Manufacturer: 10/25/2019
• Supplement Date Received by Manufacturer: 12/27/2019
• Initial Report FDA Received Date: 11/22/2019
• Supplement Report FDA Received Date: 01/21/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 52 YR
• Date Report Sent to FDA: 01/01/2005