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	10/01/2021
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.
Event or Problem Description
The patient was undergoing a coil embolization procedure in the gastric artery using ruby coil lps, lp system detachment handle (handle), and a non-penumbra microcatheter.During the procedure, the physician advanced a ruby coil lp into the vessel and attempted to detach it using a handle; however, the ruby coil lp failed to detach.Therefore, the ruby coil lp was removed.The procedure was completed using new ruby coil lps and the same handle.There was no report of an adverse effect to the patient.
Additional Manufacturer Narrative
Evaluation of the returned ruby coil lp revealed, that the embolization coil was detached inside the introducer sheath.Evaluation also revealed, the pet lock was wrinkled, but not separated.This indicates there may not have been a successful detachment attempt.If a detachment is attempted with the detachment handle, the pet lock will become separated.Evaluation also revealed, pusher assembly was fractured and kinked, the introducer sheath was ovalized, and the embolization coil had offset coil winds.These damages were likely, incidental to the complaint.And may have occurred, during packaging for the device return.The embolization coil likely detached, due to the incidental pusher assembly fracture.Due to the returned damage, the root cause of the reported complaint 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.Please note, that the following sections were incorrectly reported on the initial mfr report.And are being corrected, based on additional information provided by a penumbra sales representative on 11/03/2021.2.Section g: box 4, date received by manufacturer.H3 other text: placeholder.

• Brand Name: RUBY 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: 12712013
• Report Number: 3005168196-2021-02409
• Device Sequence Number: 17336942
• Product Code: HCG
• UDI-Device Identifier: 00815948021723
• UDI-Public: 00815948021723
• Combination Product (Y/N): Y
• Initial Reporter State: CA
• 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): 12/02/2021
• 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: 12/30/2025
• Device Model Number: RBYLP0102
• Device Catalogue Number: RBYLP0102
• Device Lot Number: F103073
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/03/2021
• 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: 10/01/2021
• Supplement Date Received by Manufacturer: 11/22/2021
• Initial Report FDA Received Date: 10/28/2021
• Supplement Report FDA Received Date: 12/02/2021
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/31/2020
• 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 Sex: Unknown
• Date Report Sent to FDA: 01/01/2005