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

Catalog Number	RBY4C0406
Medical Device Problem Codes	Kinked (1339); Physical Resistance (2578)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	05/07/2018
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 in the gastroduodenal artery (gda) using ruby coils.During the procedure, while inserting a ruby coil into a lantern delivery microcatheter (lantern), the physician experienced resistance and subsequently, the ruby coil pusher assembly became severely kinked; therefore, it was removed.The procedure was completed using additional ruby coils and the same lantern.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 pusher assembly was kinked approximately 5.0cm from the proximal end.The pusher assembly was bent approximately 9.5, 37.0, 62.0, 116.0, 122.0, 128.0, 150.0, 172.0, and 182.0 cm from the proximal end.The embolization coil was intact with its pusher assembly.The embolization coil had offset oil winds.Coagulated blood was found on the embolization coil.Conclusions: evaluation of the returned ruby coil revealed a kinked device and an embolization coil with offset coil winds.Coagulated blood was found on the embolization coil.If blood became coagulated on the embolization coil, this may have contribute to resistance experienced during the procedure.If the device is forcefully advanced against resistance, damage such as offset coil winds and kinking may occur.Further evaluation revealed bends along the length of the pusher assembly.Based on the return condition of the ruby coil, it is likely that the bends are incidental to the reported complaint and may have occurred during packaging for return to penumbra.Penumbra coils are visually 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: 7573712
• Report Number: 3005168196-2018-01116
• Device Sequence Number: 217543
• Product Code: HCG
• UDI-Device Identifier: 00814548013169
• UDI-Public: 00814548013169
• 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: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 05/07/2018
• 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: Physician
• Device Expiration Date: 02/14/2026
• Device Catalogue Number: RBY4C0406
• Device Lot Number: F81944
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/18/2018
• Was the Report Sent to FDA?: Yes
• Date Report to Manufacturer: 01/10/2005
• Initial Date Received by Manufacturer: 05/07/2018
• Supplement Date Received by Manufacturer: 07/30/2018
• Initial Report FDA Received Date: 06/06/2018
• Supplement Report FDA Received Date: 07/30/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 84 YR
• Patient Weight: 86
• Date Report Sent to FDA: 01/01/2005