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

Model Number	RBYPCLP03
Medical Device Problem Code	Material Deformation (2976)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	02/17/2020
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.
Event or Problem Description
The patient was undergoing a coil embolization procedure in the left colic artery using ruby coil lps and a non-penumbra microcatheter.During the procedure, the pusher wire became kinked while advancing the ruby coil lp into the microcatheter.Therefore, the ruby coil lp was removed.The procedure was completed using another ruby coil lp.There was no report of an adverse effect to the patient.
Additional Manufacturer Narrative
Please note that the following sections were incorrectly reported on the initial mfr report and are being corrected on this follow-up # 1 mfr report: section b.Box 5.Describe event or problem; section d.Box 1.Brand name.
Event or Problem Description
The patient was undergoing a coil embolization procedure in the left colic artery using packing coil lps and a non-penumbra microcatheter.During the procedure, the pusher wire became kinked while advancing the packing coil lp into the microcatheter.Therefore, the packing coil lp was removed.The procedure was completed using another packing coil lp.There was no report of an adverse effect to the patient.

• Brand Name: PACKING COIL LP
• 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: 9826214
• Report Number: 3005168196-2020-00345
• Device Sequence Number: 1367497
• Product Code: HCG
• UDI-Device Identifier: 00815948021891
• UDI-Public: 00815948021891
• Combination Product (Y/N): Y
• Initial Reporter State: PA
• Initial Reporter Country: US
• PMA/510(K) Number: K192955
• 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,Followup
• Report Date (Section B): 09/06/2024
• 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: 12/17/2024
• Device Model Number: RBYPCLP03
• Device Catalogue Number: RBYPCLP03
• Device Lot Number: F95063
• Was Device Available for Evaluation?: No
• 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: 02/17/2020
• Supplement Date Received by Manufacturer: 01/14/2005
• Initial Report FDA Received Date: 03/12/2020
• Supplement Report FDA Received Date: 09/06/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 12/19/2019
• 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
• Patient Age: 30 YR
• Patient Sex: Male
• Patient Weight: 91 KG
• Date Report Sent to FDA: 01/01/2005