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

Model Number	RBY2C0725-B
Medical Device Problem Codes	Device Dislodged or Dislocated (2923); Migration (4003); Physical Resistance/Sticking (4012)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/03/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The product was not returned for evaluation.Without the return of the device, the root cause of the problem cannot be determined.The manufacturing records for this lot were reviewed and did not reveal any outstanding discrepancies, design, or quality concerns.This report is associated with mfr report numbers: 3005168196-2021-01446, 3005168196-2021-01448, and 3005168196-2021-01449.
Event or Problem Description
The patient was undergoing a coil embolization procedure in the subclavian artery using ruby coils, lantern delivery microcatheters (lantern), a non-penumbra sheath, and a 4f glide catheter.During the procedure, the physician advanced two ruby coils into the target vessel using the lantern; however, both coils were determined to be oversized.Therefore, both ruby coils were removed.The physician then attempted to advance a new ruby coil through the lantern; however, the ruby coil would not advance.Upon further inspection, the physician noticed a kink towards the hub of the lantern.Therefore, the ruby coil was removed and saved for later use.The physician then removed the damaged lantern and inserted a new lantern into the patient.Afterwards, the physician implanted the previously removed ruby coil in the target vessel.While advancing a new ruby coil through the lantern, the physician experienced resistance but was able to implant the ruby coil in the target vessel.Subsequently, when the scrub technologist was retracting the lantern without a guidewire, both ruby coils were pulled back into the brachial artery.Therefore, the physician used a snare device to remove both ruby coils.The physician decided to end the procedure at this point and planned to bring the patient back in on a later date.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: 12097699
• Report Number: 3005168196-2021-01447
• Device Sequence Number: 11750273
• Product Code: HCG
• UDI-Device Identifier: 00814548018836
• UDI-Public: 00814548018836
• Combination Product (Y/N): Y
• Initial Reporter State: NC
• 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): 06/30/2021
• 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 Model Number: RBY2C0725-B
• Device Catalogue Number: RBY2C0725
• Device Lot Number: F97500
• Was Device Available for Evaluation?: No
• 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: 06/03/2021
• Initial Report FDA Received Date: 07/01/2021
• 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: 66 YR
• Date Report Sent to FDA: 01/01/2005