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

Model Number	RBYLP0102
Medical Device Problem Code	Separation Failure (2547)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/17/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Evaluation of the returned ruby coil lp confirmed that the embolization coil was intact with the pusher assembly and revealed that the pull wire was in its initial position within the pusher assembly ddt.Evaluation also revealed that the pusher assembly, pull wire and pet lock was fractured off the proximal end of the pusher assembly.This damage was likely due to the manual detachment attempt made during the procedure.Due to the return damage, the ruby coil lp could not be functionally tested, and the root cause of the detachment issue during the procedure could not be determined.Further evaluation also revealed offset coil winds.This damage was likely incidental to the reported complaint.Evaluation of the returned ruby coil revealed a functional device.During functional testing, the ruby coil was advanced through its introducer sheath and a demonstration lantern without an issue.The reported complaint could not be confirmed, and the root cause could not be determined.Penumbra coils are 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.(b)(4).This report is associated with mfr report numbers: 3005168196-2021-02268, 3005168196-2021-02269, 3005168196-2021-02270, 3005168196-2021-02271, 3005168196-2021-02272, 3005168196-2021-02273, 3005168196-2021-02262, 3005168196-2021-02263, 3005168196-2021-02264, 3005168196-2021-02265, 3005168196-2021-02266.
Event or Problem Description
The patient was undergoing a coil embolization procedure in the left and right gastric branch using ruby coil lps, packing coil lps, ruby coils, a lp system detachment handle (handle), and non-penumbra microcatheters.During the procedure, the physician advanced a ruby coil lp into the left gastric branch using the first microcatheter and attempted to detach the coil using the handle; however, the ruby coil lp failed to detach.The physician then attempted to manually detach the ruby coil lp using a needle driver but, the coil still failed to detach.Therefore, the ruby coil lp was removed.Subsequently, the physician was unable to detach five ruby coil lps and four packing coil lps in the target location using the handle.Therefore, the physician used the needle driver to manually detach the packing coil lps and ruby coil lps.Next, while attempting to place a ruby coil in the right gastric branch, the physician was unable to advance a ruby coil through the tip of the second microcatheter.Therefore, the ruby coil was removed.The procedure was completed using additional ruby coils and the same microcatheter.There was no adverse effect to the patient.

• Brand Name: RUBY COIL LP
• Common Device Name: HCG, KRD
• Manufacturer (Section D): PENUMBRA, INC.; one penumbra place; alameda CA 94502
• MDR Report Key: 12619467
• Report Number: 3005168196-2021-02267
• Device Sequence Number: 3586849
• Product Code: HCG
• UDI-Device Identifier: 00815948021723
• UDI-Public: 00815948021723
• Combination Product (Y/N): Y
• Initial Reporter State: OR
• Initial Reporter Country: US
• PMA/510(K) Number: K192955
• 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): 10/12/2021
• 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 Expiration Date: 05/27/2026
• Device Model Number: RBYLP0102
• Device Catalogue Number: RBYLP0102
• Device Lot Number: F106697
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/30/2021
• 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: 09/17/2021
• Initial Report FDA Received Date: 10/12/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 80 YR
• Date Report Sent to FDA: 01/01/2005