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

Model Number	RBY4C0415-B
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Codes	No Consequences Or Impact To Patient (2199); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/07/2020
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 in multiple locations.The pusher assembly was fractured approximately 55.5 cm from its proximal end.The embolization coil was detached from its pusher assembly and not returned for evaluation.Conclusions: evaluation of the returned ruby coil confirmed that the coil was detached from its pusher assembly and revealed a fractured pusher assembly.If the ruby coil is forcefully advanced against resistance, damage such as a kink and subsequently fracture may occur.If the two fractured segments are separated, the pull wire may retract out of the distal detachment tip (ddt), and result in the embolization coil detaching from its pusher assembly.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 in the gastroduodenal artery (gda) using ruby coils and a lantern delivery microcatheter (lantern).During the procedure, the physician placed ruby coils in the target vessel using the lantern.While attempting to insert another ruby coil into the lantern, the physician noticed the ruby coil became detached within the introducer sheath; prior to entering the microcatheter.Therefore, the ruby coil was removed.The procedure was completed using additional ruby coils and the same lantern.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: 11128851
• Report Number: 3005168196-2021-00028
• Device Sequence Number: 3247203
• Product Code: HCG
• UDI-Device Identifier: 00814548018348
• UDI-Public: 00814548018348
• Combination Product (Y/N): Y
• Initial Reporter State: WI
• Initial Reporter Country: US
• PMA/510(K) Number: K173614
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 12/08/2020
• 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: RBY4C0415-B
• Device Catalogue Number: RBY4C0415
• Device Lot Number: F93497
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/17/2020
• 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: 12/08/2020
• Initial Report FDA Received Date: 01/06/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 42 YR
• Date Report Sent to FDA: 01/01/2005