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

Model Number	RBY2C2457-A
Medical Device Problem Code	Premature Separation (4045)
Health Effect - Clinical Codes	No Consequences Or Impact To Patient (2199); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/02/2020
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 using ruby coils, pod packing coils (podjs), and lantern delivery microcatheters (lantern).During the procedure, while advancing a ruby coil through a lantern, the ruby coil unintentionally detached.Therefore, the lantern containing the detached ruby coil was removed, and the ruby coil was flushed out.The lantern was noted to be kinked and therefore, was not used for the remainder of the procedure.The physician continued with the procedure and implanted another ruby coil using a new lantern.Subsequently, while advancing a podj through the lantern, the physician experienced resistance, and the podj unintentionally detached.Therefore, the lantern containing the detached podj was removed, and the podj was taken out.It was reported that the detached podj was observed to be hanging by the underlying nylon upon removal of the lantern.The procedure was completed using another podj and the same lantern.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 5.0 cm, 56.0 cm, 130.0 cm and 133.0 cm from the proximal end.The pull wire was inside its alignment feature inside the pusher assembly distal detachment tip (ddt).The embolization coil was detached from the pusher assembly and had offset coil winds along its length.The proximal constraint sphere was intact with the proximal end of the embolization coil.Conclusions: evaluation of the returned ruby coil confirmed that the embolization coil was detached from its pusher assembly and revealed that the pet lock was intact, and the pull wire was within the ddt.If the ruby coil is retracted against resistance, the pusher assembly may become elongated and the pull wire may retract out of the ddt and allow the embolization coil to detach from the pusher assembly.The resistance was likely contributed by the kinked lantern that was identified in the complaint.Further investigation of the device revealed offset coil winds along the length of the embolization coil and kinks on the pusher assembly.This damage was likely incidental to the complaint.Evaluation of the returned podj embolization coil revealed that the sr wire was fractured, and the embolization coil was unraveled.If the podj is forcefully retracted against resistance, damage such as this may occur.The root cause of the reported resistance could not be determined.Further evaluation of the device revealed offset coil winds along the length of the embolization coil.This damage was likely incidental tot the 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.Please note that the following section was inadvertently missed on the initial mfr report and is being included on this follow-up #01 mfr report: 3005168196-2020-01610.1.Section h.Box 10/11.Narrative/corrected data this report is associated with mfr report numbers: 1.3005168196-2020-01611.2.3005168196-2020-01612 h3 other text : placeholder.

• Brand Name: RUBY COIL
• Common Device Name: HCG, KRD
• Manufacturer (Section D): PENUMBRA, INC.; one penumbra place; alameda CA 94502
• MDR Report Key: 10609933
• Report Number: 3005168196-2020-01610
• Device Sequence Number: 13773409
• Product Code: HCG
• UDI-Device Identifier: 00814548013084
• UDI-Public: 00814548013084
• Combination Product (Y/N): Y
• Initial Reporter Country: UK
• 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: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 09/02/2020
• 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: RBY2C2457-A
• Device Catalogue Number: RBY2C2457
• Device Lot Number: F90315
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/02/2020
• Was the Report Sent to FDA?: Yes
• Date Report to Manufacturer: 01/10/2005
• Initial Date Received by Manufacturer: 09/02/2020
• Supplement Date Received by Manufacturer: 11/12/2020
• Initial Report FDA Received Date: 09/30/2020
• Supplement Report FDA Received Date: 11/28/2020
• 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