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

Catalog Number	RBY2C0825
Medical Device Problem Code	Kinked (1339)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	05/23/2018
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, the distal end of a ruby coil pusher assembly became kinked as the hospital staff was advancing it out of the introducer sheath and into a lantern delivery microcatheter (lantern).The ruby coil was, therefore, removed, and the procedure was completed using a new ruby coil.There was no report of an adverse effect to the patient.
Additional Manufacturer Narrative
Results: the pet lock was intact on the proximal end of the pusher assembly.The embolization coil was intact with the pusher assembly and the coil was undamaged.The pusher assembly was kinked approximately 20.0 cm, 39.0 cm, 57.0 cm, 78.0 cm, 105.0 cm and 107.0 cm from the proximal end.The coil was able to be advanced out of its introducer sheath and through a demonstration microcatheter without any issue.Conclusions: evaluation of the returned device revealed there were kinks along the length of the pusher assembly.If the device is forcefully advanced against resistance, the pusher assembly may become kinked.Further damage to the pusher assembly may have occurred during packaging for return to penumbra.During functional testing, the returned ruby coil was able to be advanced through a demonstration microcatheter without an issue.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: 7626320
• Report Number: 3005168196-2018-01222
• Device Sequence Number: 13903066
• Product Code: HCG
• UDI-Device Identifier: 00814548012971
• UDI-Public: 00814548012971
• Combination Product (Y/N): Y
• Initial Reporter State: PA
• 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: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 05/23/2018
• 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: 03/10/2026
• Device Catalogue Number: RBY2C0825
• Device Lot Number: F82260
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/08/2018
• Was the Report Sent to FDA?: Yes
• Date Report to Manufacturer: 01/10/2005
• Initial Date Received by Manufacturer: 05/23/2018
• Supplement Date Received by Manufacturer: 10/19/2018
• Initial Report FDA Received Date: 06/21/2018
• Supplement Report FDA Received Date: 10/19/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 78 YR
• Date Report Sent to FDA: 01/01/2005