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

Model Number	RBY4C1650-A
Medical Device Problem Code	Failure to Advance (2524)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/15/2021
Type of Reportable Event	Malfunction
Event or Problem Description
The patient was undergoing a coil embolization procedure in the splenic artery using ruby coils, pod packing coils (pod pc), a new handle, a non-penumbra microcatheter, and a guidewire.During the procedure, the physician successfully implanted two ruby coils in the target vessel using the handle and microcatheter.While attempting to advance the next ruby coil, the coil would not advance at all past its initial position within its introducer sheath.Therefore, the ruby coil was removed.The physician then successfully implanted another ruby coil and four pod pcs in the target vessel using the handle and microcatheter.Next, the physician advanced another pod pc to the target vessel using the microcatheter; however, the pod pc was determined to be too long.Therefore, the pod pc was removed intact.The physician then successfully implanted another pod pc in the target vessel using the same handle and microcatheter.The procedure was completed at this point.There was no report of an adverse effect to the patient.
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.
Additional Manufacturer Narrative
Evaluation of the returned ruby coil could not confirm the reported complaint that the device could not advance past its initial position within the introducer sheath.Evaluation revealed that the embolization coil had offset coil winds, and the pusher assembly had kinks.This damage typically occurs if the device is advanced against resistance, indicating that the coil was likely able to advance beyond its starting position during the procedure.The ruby coil was unable to be manipulated within its introducer sheath during the functional test due to the offset coil winds.Based on the reported complaint, the root cause of resistance could not be determined.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.

• Brand Name: RUBY COIL
• Common Device Name: HCG, KRD
• Manufacturer (Section D): PENUMBRA, INC.; one penumbra place; alameda CA 94502
• Manufacturer Contact: veronica farris ; one penumbra place; alameda, CA 94502 ; 5107483200
• MDR Report Key: 12784222
• Report Number: 3005168196-2021-02541
• Device Sequence Number: 14473380
• Product Code: HCG
• UDI-Device Identifier: 00814548013244
• UDI-Public: 00814548013244
• Combination Product (Y/N): N
• Initial Reporter State: NJ
• Initial Reporter Country: US
• PMA/510(K) Number: K120330
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 11/09/2021
• 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?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 02/07/2025
• Device Model Number: RBY4C1650-A
• Device Catalogue Number: RBY4C1650
• Device Lot Number: F74391
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/26/2021
• Is the Reporter a Health Professional?: Yes
• 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: 10/15/2021
• Supplement Date Received by Manufacturer: 11/16/2021
• Initial Report FDA Received Date: 11/10/2021
• Supplement Report FDA Received Date: 12/01/2021
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/09/2017
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Age: 60 YR
• Patient Sex: Male
• Date Report Sent to FDA: 01/01/2005