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

Model Number	RBY2C0435-A
Medical Device Problem Codes	Unraveled Material (1664); Physical Resistance/Sticking (4012)
Health Effect - Clinical Codes	No Consequences Or Impact To Patient (2199); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/16/2020
Type of Reportable Event	Serious Injury
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.
Event or Problem Description
The patient was undergoing a coil embolization procedure to treat a fistula in the collateral artery using ruby coils and non-penumbra microcatheter.During the procedure, the physician placed multiple ruby coils in the target vessel using a non-penumbra microcatheter.While attempting to advance another ruby coil, the physician lost access with the microcatheter to the target vessel and, therefore, decided to remove the ruby coil.However, while retracting the ruby coil, the physician experienced resistance and the ruby coil became unraveled.The physician, therefore used an indigo system catd aspiration catheter (catd) with aspiration and a snare device to remove the ruby coil.The procedure was completed using a new ruby coil and the same microcatheter.There was no report of an adverse effect to the patient.
Additional Manufacturer Narrative
Results: the ruby coil pusher assembly was removed from the non-penumbra microcatheter.Bends and kinks were present throughout the length of the pusher assembly.The pet lock was intact on the proximal end of the pusher assembly.The embolization coil was detached from the pusher assembly and had offset coil winds throughout its length.The proximal constraint sphere was within the pusher assembly distal detachment tip (ddt).Conclusions: evaluation of the returned ruby coil confirmed a detached embolization coil and revealed that the proximal constraint sphere was within the pusher assembly ddt.This indicates that the detached coil was a result of a fractured stretch resistance wire (sr wire).If the ruby coil is forcefully retracted against resistance, the sr wire may fracture causing the embolization coil to detach and unravel.Further evaluation revealed pusher assembly bends and kinks.This damage was likely incidental to the reported complaint.Evaluation of the non-penumbra microcatheter revealed ovalizations.The root cause of this damage could not be determined; however, this damage may have contributed to resistance while retracting the ruby coil during the procedure.Penumbra coils 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.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: 10656736
• Report Number: 3005168196-2020-01680
• Device Sequence Number: 11650819
• Product Code: HCG
• UDI-Device Identifier: 00814548012889
• UDI-Public: 00814548012889
• Combination Product (Y/N): Y
• Initial Reporter State: ND
• 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: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 09/16/2020
• 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?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 02/21/2026
• Device Model Number: RBY2C0435-A
• Device Catalogue Number: RBY2C0435
• Device Lot Number: F82041
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/06/2020
• Was the Report Sent to FDA?: Yes
• Date Report to Manufacturer: 01/10/2005
• Initial Date Received by Manufacturer: 09/16/2020
• Supplement Date Received by Manufacturer: 11/09/2020
• Initial Report FDA Received Date: 10/09/2020
• Supplement Report FDA Received Date: 12/09/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 55 YR
• Date Report Sent to FDA: 01/01/2005