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

Model Number	RBY2C1260-A
Medical Device Problem Codes	Material Deformation (2976); Physical Resistance/Sticking (4012)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	02/03/2020
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: 1.3005168196-2020-00266.
Event or Problem Description
The patient was undergoing a coil embolization procedure using ruby coils and a non-penumbra microcatheter.During the procedure, while advancing a ruby coil through the microcatheter, the ruby coil became stuck and subsequently its pusher assembly kinked.Therefore, the ruby coil was removed.The physician then advanced another ruby coil through the microcatheter; however, the same issue occurred and the ruby coil was therefore removed.No additional information regarding the completion of the procedure was provided.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 had kinks on multiple locations throughout its length.The pusher assembly was fractured approximately 24.5 cm from the proximal end.The embolization coil was detached from the pusher assembly and had offset coil winds along its length.Conclusions: evaluation of the first returned ruby coil revealed a fractured pusher assembly.If the device is forcefully advanced against resistance, damage such as a pusher assembly kink may occur.Subsequently, if a kinked device is further manipulated, the kink may worsen to a fracture.Further evaluation revealed a detached embolization coil with offset coil winds and additional pusher assembly kinks.The detached embolization coil was likely a result of the pusher assembly fracture.Some of the offset coil winds and the additional pusher assembly kinks may be incidental to the reported complaint and may have occurred during packaging for return to penumbra.Evaluation of the second returned ruby coil revealed a fractured pusher assembly.If the device is forcefully advanced against resistance, damage such as a pusher assembly kink may occur.Subsequently, if a kinked device is further manipulated, the kink may worsen to a fracture.Further evaluation revealed offset coils winds along the embolization coil.This damage was likely a result of forceful advancement against resistance.The non-penumbra microcatheter identified in the complaint was not returned for evaluation; therefore, the root cause of the initial resistance experience during the procedure could not be determined.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.This report is associated with mfr report number: 3005168196-2020-00266.

• Brand Name: RUBY COIL
• Common Device Name: HCG, KRD
• Manufacturer (Section D): PENUMBRA, INC.; one penumbra place; alameda CA 94502
• MDR Report Key: 9767808
• Report Number: 3005168196-2020-00265
• Device Sequence Number: 19555759
• Product Code: HCG
• UDI-Device Identifier: 00814548013022
• UDI-Public: 00814548013022
• 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: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 02/07/2020
• 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 Model Number: RBY2C1260-A
• Device Catalogue Number: RBY2C1260
• Device Lot Number: F92984
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/03/2020
• Was the Report Sent to FDA?: Yes
• Date Report to Manufacturer: 01/10/2005
• Initial Date Received by Manufacturer: 02/07/2020
• Supplement Date Received by Manufacturer: 05/12/2020
• Initial Report FDA Received Date: 02/28/2020
• Supplement Report FDA Received Date: 05/14/2020
• 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