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

Catalog Number	RBY4C0620
Medical Device Problem Code	Premature Separation (4045)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	12/20/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
This device is available for return.A follow up mdr will be submitted upon completion of the device investigation.
Event or Problem Description
The patient was undergoing a coil embolization procedure using ruby coils.During the procedure, a ruby coil unintentionally detached within the non-penumbra microcatheter.The physician then pulled the ruby coil from the microcatheter by hand.The procedure was completed using additional ruby coils and the same non-penumbra microcatheter.There was no report of an adverse effect to the patient.
Additional Manufacturer Narrative
Results: the pet lock was intact at the proximal end of the pusher assembly.Bends and kinks were present along the length of the pusher assembly approximately 5.0 cm, 16.0 cm, 38.0 cm, 54.5 cm, 77.0 cm, 87.0 cm, 99.0 cm, 109.0 cm, 123.0 cm, 142.5 cm, 151.5 cm and 164.0 cm from the proximal end.The pull wire was intact at the pusher assembly distal detachment tip (ddt).The proximal constraint sphere was intact with the embolization coil.The embolization coil had minor offset coil winds.Conclusions: evaluation of the returned ruby coil confirmed a detached embolization coil.If there is resistance while the ruby coil is within the non-penumbra microcatheter and the device is subsequently retracted against that resistance, the embolization coil may unintentionally detach.The non-penumbra microcatheter and introducer sheath associated with the ruby coil were not returned for evaluation; therefore, the root cause of the unintentional detachment could not be determined.Further evaluation revealed kinks along the pusher assembly.These kinks were likely incidental to the reported complaint and may have occurred during packaging for return to penumbra.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.

• Brand Name: RUBY COIL
• Common Device Name: HCG, KRD
• Manufacturer (Section D): PENUMBRA, INC.; one penumbra place; alameda CA 94502
• MDR Report Key: 8261596
• Report Number: 3005168196-2019-00125
• Device Sequence Number: 16178322
• Product Code: HCG
• UDI-Device Identifier: 00814548013183
• UDI-Public: 00814548013183
• Combination Product (Y/N): Y
• Initial Reporter State: CA
• 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): 12/20/2018
• 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: 06/12/2024
• Device Catalogue Number: RBY4C0620
• Device Lot Number: F70131
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/22/2019
• Was the Report Sent to FDA?: Yes
• Date Report to Manufacturer: 01/10/2005
• Initial Date Received by Manufacturer: 12/20/2018
• Supplement Date Received by Manufacturer: 04/05/2019
• Initial Report FDA Received Date: 01/18/2019
• Supplement Report FDA Received Date: 05/03/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 58 YR
• Date Report Sent to FDA: 01/01/2005