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

Catalog Number	RBY4C0305
Medical Device Problem Codes	Detachment Of Device Component (1104); Retraction Problem (1536); Physical Resistance (2578)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	12/22/2017
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.This report is associated with mfr report number: 3005168196-2018-00318.
Event or Problem Description
The patient was undergoing a coil embolization procedure treating an ileal lymphoma using a lantern delivery microcatheter (lantern) and ruby coils.During the procedure, while advancing a ruby coil through the lantern, the physician experienced resistance and therefore attempted to retract the ruby coil.However, upon retraction, the physician noticed that the ruby coil had unintentionally detached from its pusher wire, and therefore the physician removed the lantern with the detached ruby coil inside.Upon removal, it was found that the lantern was kinked.The procedure was then completed using a new lantern and additional ruby coils.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 5.0, 57.0, 89.0, and 95.0 cm from the proximal end.The embolization coil was intact with its pusher assembly.Prior to decontamination contrast was observed on the distal tip of the introducer sheath conclusions: evaluation of the returned lantern confirmed that the device was kinked.If the device is forcefully manipulated at extreme angles, damage such as this may occur.Further evaluation of the returned device revealed that the lantern was ovalized.If the device is forcefully gripped or pinched during insertion, damage such as this may occur.The kinks and ovalization in the lantern may have contributed to the reported resistance.Evaluation of the returned ruby coil revealed that the embolization coil was intact with its pusher assembly.Therefore, the root cause of the reported unintentional detachment could not be determined.Further evaluation of the returned device revealed that the pusher assembly was kinked.These kinked were likely caused due to forceful advancement against resistance and from the returned packaging condition upon return to penumbra.Penumbra coils and catheters 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.This report is associated with mfr report number: 3005168196-2018-00318.

• Brand Name: RUBY COIL
• Common Device Name: HCG, KRD
• Manufacturer (Section D): PENUMBRA, INC.; one penumbra place; alameda CA 94502
• MDR Report Key: 7252060
• Report Number: 3005168196-2018-00319
• Device Sequence Number: 16178024
• Product Code: HCG
• UDI-Device Identifier: 00814548013145
• UDI-Public: 00814548013145
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: K120330
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 01/12/2018

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: 07/24/2025
• Device Catalogue Number: RBY4C0305
• Device Lot Number: F78357
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/30/2018
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 01/12/2018
• Supplement Date Received by Manufacturer: 04/10/2018
• Initial Report FDA Received Date: 02/08/2018
• Supplement Report FDA Received Date: 04/17/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 52 YR