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

Catalog Number	RBY2C0725
Medical Device Problem Code	Failure to Advance (2524)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	06/01/2018
Type of Reportable Event	Malfunction
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 cm from the proximal end of the pusher and bent 10.0, 59.5, 71.0, 80.5, 95.0, and 102.0 cm from the proximal end of the pusher.The embolization coil was intact with the distal detachment tip (ddt) but the ddt was fractured from the rest of the pusher assembly.The embolization coil had offset coil winds.Dried coagulated blood was present along the length of the embolization coil and pusher assembly.Conclusions: evaluation of the returned ruby coil revealed a device with a fractured pusher assembly.If the introducer sheath is not properly aligned within the hub of the microcatheter prior to advancement, damage such as offset coil winds may occur.If damage such as offset coils are present, resistance may be felt when advancing the device.If the device is subsequently retracted while experiencing resistance, damage such as a fractured ddt may occur.Further evaluation found coagulated blood present on the embolization coil and pusher assembly.If continuous flush was not used, blood may back flow into the introducer sheath and coagulate on the device.Further evaluation revealed kinks and bends along the length of the device.If the ruby coil is advanced or retracted while experiencing resistance, damage such as a kink or bend may occur.Additionally, based on return condition and the reported complaint, some bends and the kink are likely 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.
Event or Problem Description
The patient was undergoing a coil embolization procedure using ruby coil.During the procedure, the physician was unable to advance a ruby coil out of its introducer sheath and into a non-penumbra microcatheter.It is unknown how the procedure was completed; however, there was no report of an adverse effect to the patient.

• Brand Name: RUBY COIL
• Common Device Name: HCG, KRD
• Manufacturer (Section D): PENUMBRA, INC.; one penumbra place; alameda CA 94502
• MDR Report Key: 7768098
• Report Number: 3005168196-2018-01548
• Device Sequence Number: 173840
• Product Code: HCG
• UDI-Device Identifier: 00814548012957
• UDI-Public: 00814548012957
• Combination Product (Y/N): Y
• Initial Reporter Country: GM
• 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: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 07/11/2018
• 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: Health Professional
• Device Expiration Date: 06/04/2024
• Device Catalogue Number: RBY2C0725
• Device Lot Number: C05526
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/19/2018
• Was the Report Sent to FDA?: Yes
• Date Report to Manufacturer: 01/10/2005
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/11/2018
• Initial Report FDA Received Date: 08/09/2018
• 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