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

Catalog Number	RBY2C1035
Medical Device Problem Codes	Failure to Advance (2524); Physical Resistance/Sticking (4012)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	10/02/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device has been returned and the investigation results are pending.A follow up mdr will be submitted upon completion of the device investigation.This report is associated with mfr report number: 3005168196-2019-02027.
Event or Problem Description
The patient was undergoing a coil embolization procedure in the renal artery 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 subsequently, the ruby coil became stuck at the distal end of the lantern.The physician attempted to push the ruby coil through the lantern but was unable to get the ruby coil to move.The physician then attempted flush the ruby coil out of the lantern and into the aneurysm; however, the ruby coil remained stuck in the same location.Therefore, the ruby coil and lantern were removed from the patient.The procedure was completed using a new lantern and 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 pusher assembly was fractured approximately 63.0 cm from the proximal end.The pusher assembly was kinked approximately 64.0 and from 168.0 ¿ 169.0 cm from the proximal end.The embolization coil was detached from the pusher assembly and was within the lantern.Offset coil winds were present on the proximal end of the embolization coil.Conclusions: evaluation of the returned lantern revealed an ovalization on the distal tip.If the device is gripped or pinched during use, damage such as an ovalization may occur.During functional testing, a demonstration mandrel was unable to advance through the lantern due to the ovalization.The ovalization likely contributed to the resistance experienced during the procedure and during the functional testing.Evaluation of the returned ruby coil revealed a kinked and fractured pusher assembly, a detached embolization coil and offset coil winds on the proximal end of the embolization coil.If the ruby coil is forcefully advanced against resistance, damage such as offset coil winds and a kinked pusher assembly may occur.Further manipulation of a kinked pusher assembly may result in a fracture which may cause the embolization coil to detach.Further evaluation revealed additional pusher assembly kinks.These kinks were likely incidental to the reported complaint.Penumbra coils and catheters 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.This report is associated with mfr report number: 3005168196-2019-02027.

• Brand Name: RUBY COIL
• Common Device Name: HCG, KRD
• Manufacturer (Section D): PENUMBRA, INC.; one penumbra place; alameda CA 94502
• MDR Report Key: 9268365
• Report Number: 3005168196-2019-02028
• Device Sequence Number: 2498011
• Product Code: HCG
• UDI-Device Identifier: 00814548013008
• UDI-Public: 00814548013008
• Combination Product (Y/N): Y
• Initial Reporter Country: BE
• 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): 10/03/2019
• 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 Catalogue Number: RBY2C1035
• Device Lot Number: F90803
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/21/2019
• Was the Report Sent to FDA?: Yes
• Date Report to Manufacturer: 01/10/2005
• Initial Date Received by Manufacturer: 10/03/2019
• Supplement Date Received by Manufacturer: 11/13/2019
• Initial Report FDA Received Date: 11/01/2019
• Supplement Report FDA Received Date: 11/22/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Date Report Sent to FDA: 01/01/2005