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

Model Number	RBY4C0835-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	08/25/2020
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: 3005168196-2020-01505.
Event or Problem Description
The patient was undergoing a coil embolization procedure in the internal iliac artery using ruby coils and a non-penumbra microcatheter.During the procedure, while moving a ruby coil to make it form, the ruby coil unintentionally detached in the microcatheter.Subsequently, the microcatheter containing the detached ruby coil was removed.The physician continued with the procedure using another ruby coil and the same microcatheter.While advancing the ruby coil through the microcatheter, the physician experienced resistance, and the ruby coil unintentionally detached in the microcatheter.Therefore, the microcatheter containing the detached ruby coil was removed again.The procedure was completed using non-penumbra coils and another 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 its pusher assembly.The pusher assembly was fractured approximately 88.5 cm from its proximal end inside its introducer sheath.The pusher assembly was kinked approximately 5.0 cm from its proximal end.The embolization coil was detached from its pusher assembly and the sr wire was fractured.Conclusions: evaluation of the first returned ruby coil confirmed a detached embolization coil and revealed a fractured pusher assembly.If the ruby coil is forcefully manipulated against resistance, damage such as kink and subsequently fracture may occur.If the two fractured segments are separated, the pull wire will likely be retracted out of the distal detachment tip (ddt), and the embolization will detach from its pusher assembly.Further evaluation of the returned ruby coil revealed offset coil winds throughout the length of the embolization coil.This damage was likely incidental to the reported complaint.Evaluation of the second returned ruby coil confirmed a detached embolization coil and revealed a fractured pusher assembly.If the ruby coil is forcefully manipulated against resistance, damage such as kink and subsequently fracture may occur.If the two fractured segments are separated, the pull wire will likely be retracted out of the distal detachment tip (ddt), and the embolization will detach from its pusher assembly.Further evaluation of the second returned ruby coil revealed a kink near the proximal end of the pusher assembly and sr wire fracture.The kink was likely incidental to the reported complaint.The root cause of the sr wire fractured could not be determined.Penumbra coils are visually inspected during in-process inspection and during quality inspection after manufacturing.This report is associated with mfr report number: 1.3005168196-2020-01505.

• Brand Name: RUBY COIL
• Common Device Name: HCG, KRD
• Manufacturer (Section D): PENUMBRA, INC.; one penumbra place; alameda CA 94502
• MDR Report Key: 10551371
• Report Number: 3005168196-2020-01506
• Device Sequence Number: 19581384
• Product Code: HCG
• UDI-Device Identifier: 00814548018386
• UDI-Public: 00814548018386
• 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: distributor,foreign,health pr
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 08/25/2020
• 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: RBY4C0835-B
• Device Catalogue Number: RBY4C0835-B
• Device Lot Number: F95436
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/02/2020
• Was the Report Sent to FDA?: Yes
• Date Report to Manufacturer: 01/10/2005
• Initial Date Received by Manufacturer: 08/25/2020
• Supplement Date Received by Manufacturer: 10/01/2020
• Initial Report FDA Received Date: 09/17/2020
• Supplement Report FDA Received Date: 10/28/2020
• 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