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

Model Number	RBYLP0415
Medical Device Problem Code	Failure to Advance (2524)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/25/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Evaluation of the first returned ruby coil lp revealed that the pusher assembly mid-joint was retracted through the introducer sheath friction lock.If this occurs, resistance may be experienced during advancement.Forceful advancement against this resistance may have contributed to the kink proximal to the pusher assembly mid-joint.During functional testing, the pusher assembly mid-joint was advanced through the introducer sheath friction lock without an issue.However, resistance was encountered due to an unknown substance inside the introducer sheath and the pusher assembly could not be advanced any further.Further evaluation revealed additional kinks in the pusher assembly.This damage was incidental to the reported complaint and may have occurred during packaging for return.Evaluation of the second returned ruby coil lp revealed that the pusher assembly mid-joint was retracted through the introducer sheath friction lock.If this occurs, resistance may be experienced during advancement.Forceful advancement against this resistance likely contributed to the kink observed near the pusher assembly mid-joint.During functional testing, the pusher assembly mid-joint was advanced through the introducer sheath friction lock with resistance, then additional resistance was encountered due to the kink in the pusher assembly and the ruby coil lp could not be advanced any further.Further evaluation of the device revealed that the pet lock was damaged.This damage was likely incidental to the complaint.Evaluation of the first returned packing coil lp revealed that the pusher assembly mid-joint was distal to the introducer sheath friction lock, therefore, the complaint cannot be determined.Further evaluation revealed a pusher assembly kink and fracture, and offset coil winds on the proximal end of the embolization coil.Based on the reported complaint, this damage was incidental, and the root cause could not be determined.During the functional test, resistance was encountered while attempting to advance the pusher assembly through its introducer sheath due to the offset coil winds on the proximal end of the embolization coil, and no further testing could be performed.Evaluation of the second returned packing coil lp revealed that the pusher assembly mid-joint was retracted through the introducer sheath friction lock.If this occurs, resistance may be experienced during advancement.Forceful advancement against this resistance likely contributed to the stretching observed near the proximal end of the introducer sheath.During functional testing, the pusher assembly mid-joint was advanced through the introducer sheath friction lock with resistance, then the device was able to advance through the introducer sheath with additional resistance due to the stretching on the proximal end of the introducer sheath.Further evaluation of the device revealed that the pet lock was damaged.This damage was likely incidental to the complaint.Penumbra products 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.This report is associated with mfr report numbers: 3005168196-2021-02650, 3005168196-2021-02652, 3005168196-2021-02653.
Event or Problem Description
The patient was undergoing a coil embolization procedure in the gastroduodenal artery (gda) using ruby coil lps and packing coil lps.During the procedure, two ruby coil lps and two packing coil lps would not advance at all from their initial position within their respective introducer sheaths.Therefore, the two ruby coil lps and two packing coil lps were removed.The procedure was completed using ruby coil lps and packing coil lps.There was no report of an adverse effect to the patient.

• Brand Name: RUBY COIL LP
• 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: 12850641
• Report Number: 3005168196-2021-02651
• Device Sequence Number: 11763475
• Product Code: HCG
• UDI-Device Identifier: 00815948021815
• UDI-Public: 00815948021815
• Combination Product (Y/N): N
• Initial Reporter State: HI
• Initial Reporter Country: US
• PMA/510(K) Number: K192955
• 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
• Report Date (Section B): 11/22/2021
• 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: 09/02/2025
• Device Model Number: RBYLP0415
• Device Catalogue Number: RBYLP0415
• Device Lot Number: F99996
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/08/2021
• 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: 10/25/2021
• Initial Report FDA Received Date: 11/22/2021
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/03/2020
• 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: 58 YR
• Patient Sex: Male
• Date Report Sent to FDA: 01/01/2005