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

Model Number	RBY4C0406-A
Medical Device Problem Code	Detachment Of Device Component (1104)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	01/25/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Results: the pet lock was intact on the proximal end of the ruby coil pusher assembly.The pusher assembly was bent in multiple locations throughout its length.The embolization coil was detached from the pusher assembly and the stretch resistant wire (sr wire) was fractured.Conclusions: evaluation of the returned device revealed the sr wire was fractured and the embolization coil was detached.Fracture of the sr wire typically occurs due to forceful retraction of the ruby coil against resistance, and will allow the embolization coil to detach from the pusher assembly.Further evaluation revealed the pusher assembly was bent in multiple locations.These bends were likely incidental and may have occurred during packaging for return to penumbra.The lantern mentioned in the complaint was not returned for evaluation.Penumbra coils and catheters are 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 coils.During the procedure, while advancing a ruby coil through a lantern delivery microcatheter (lantern), the lantern shifted out of place; therefore, the physician attempted to retract and re-sheath the ruby coil.While retracting the ruby coil, it unintentionally detached within the lantern; therefore the lantern was removed with the ruby coil inside.The physician then decided that the procedure was completed at this point.In addition, the physician reported not using a rotating hemostasis valve and not maintaining continuous flush.There was no report of an adverse effect to the patient.
Additional Manufacturer Narrative
Please note that the following section was incorrectly reported on the initial mfr report and is being corrected on this follow-up #01 mfr report: 3005168196-2017-00238.Section b.Box 5.Describe event or problem.
Event or Problem Description
The patient was undergoing a coil embolization procedure using ruby coils.During the procedure, the physician successfully placed a ruby coil using a lantern delivery microcatheter (lantern).The physician then attempted to place another ruby coil, however while advancing the coil through the lantern, the lantern shifted out of place.The physician therefore attempted to retract and re-sheath the ruby coil.While retracting the ruby coil, it unintentionally detached within the lantern; therefore the lantern was removed with the ruby coil inside.The physician then decided that the procedure was completed at this point.In addition, the physician reported not using a rotating hemostasis valve and not maintaining continuous flush.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: 6358310
• Report Number: 3005168196-2017-00238
• Device Sequence Number: 996603
• Product Code: HCG
• UDI-Device Identifier: 00814548013169
• UDI-Public: 00814548013169
• Combination Product (Y/N): Y
• Initial Reporter State: KS
• Initial Reporter Country: US
• PMA/510(K) Number: K120330
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 01/25/2017
• 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: Physician
• Device Expiration Date: 06/30/2020
• Device Model Number: RBY4C0406-A
• Device Catalogue Number: RBY4C0406
• Device Lot Number: F64383
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/08/2017
• Was the Report Sent to FDA?: Yes
• Date Report to Manufacturer: 01/10/2005
• Initial Date Received by Manufacturer: 01/25/2017
• Supplement Date Received by Manufacturer: 01/14/2005
• Initial Report FDA Received Date: 02/24/2017
• Supplement Report FDA Received Date: 02/19/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 61 YR
• Date Report Sent to FDA: 01/01/2005