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

Model Number	RBY4C1035-B
Medical Device Problem Codes	Physical Resistance/Sticking (4012); Premature Separation (4045)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	01/30/2020
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.
Event or Problem Description
The patient was undergoing a coil embolization procedure in the internal iliac artery (iia) using ruby coils, pod packing coil (podj) and, non-penumbra microcatheter.It was noted that the patient anatomy was highly tortuous, slightly calcified and narrowed.During the procedure, the physician successfully implanted a ruby coil and a podj in the target vessel using the microcatheter.The physician then experienced resistance after advancing another ruby coil at approximately 10 to 15 centimeters from the distal end of the introducer sheath and decided to remove the ruby coil.However, upon removal of the ruby coil, the physician noticed that the ruby coil unintentionally detached at the proximal end of the microcatheter.Therefore, the microcatheter containing the detached ruby coil was removed and the ruby coil was flushed out.The procedure was completed using additional ruby coils, pod pcs and the same microcatheter.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 15.0, 62.0, and 142.0 cm from the proximal end.The pusher assembly was fractured approximately 5.0 cm from the proximal end.The embolization coil was detached from its pusher assembly inside the introducer sheath.The pull wire was advanced distal to the distal detachment tip (ddt).The introducer sheath was kinked approximately 69.5 cm from the distal tip.Conclusions: evaluation of the returned ruby coil confirmed that the embolization coil was detached from its pusher assembly, in addition, the pull wire was not within the ddt alignment feature and advanced distal to the ddt.If the ruby coil is forcefully manipulated against resistance, the pusher assembly may elongate beyond the reach of the distal tip of the pull wire and the embolization coil may detach.Further evaluation of the ruby coil revealed a pusher assembly fracture, pusher assembly kinks and a kinked introducer sheath.These damages were likely incidental to the reported complaint.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: 9735395
• Report Number: 3005168196-2020-00232
• Device Sequence Number: 13541317
• Product Code: HCG
• UDI-Device Identifier: 00814548018669
• UDI-Public: 00814548018669
• Combination Product (Y/N): Y
• Initial Reporter Country: JA
• PMA/510(K) Number: K173614
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,distri
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 01/30/2020
• 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: RBY4C1035-B
• Device Catalogue Number: RBY4C1035
• Device Lot Number: F87018
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/20/2020
• Was the Report Sent to FDA?: Yes
• Date Report to Manufacturer: 01/10/2005
• Initial Date Received by Manufacturer: 01/30/2020
• Supplement Date Received by Manufacturer: 03/23/2020
• Initial Report FDA Received Date: 02/20/2020
• Supplement Report FDA Received Date: 04/14/2020
• 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