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

Model Number	RBYLP0210
Medical Device Problem Code	Failure to Advance (2524)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/01/2021
Type of Reportable Event	Malfunction
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.This report is associated with mfr report number: 3005168196-2021-00905.
Event or Problem Description
The patient was undergoing a coil embolization procedure in the gastroduodenal artery (gda) using ruby coil lps.During the procedure, two ruby coil lps would not advance at all from their initial position within their introducer sheaths.Therefore, the two ruby coil lps were removed.The procedure was completed using new ruby coils.There was no report of an adverse effect to the patient.
Additional Manufacturer Narrative
Evaluation of the returned ruby coil lp revealed offset coil winds near the proximal end of the embolization coil.If the device is forcefully manipulated against resistance, damage such as this may occur.Based on the reported complaint, the root cause of the resistance could not be determined.During functional testing, the ruby coil lp was able to be advanced through its introducer sheath without an issue; therefore, the reported complaint could not be confirmed.Further evaluation of the device revealed a pusher assembly kink.This damage was likely incidental to the complaint and may have occurred during packaging for the return.Evaluation of the returned ruby coil lp revealed that the pusher assembly mid-joint was retracted proximal to the introducer sheath friction lock.If this occurs, resistance will likely be experienced while advancing the device and the device may not be advanced out of the introducer sheath.Forceful advancement against resistance likely contributed to the kinks in the pusher assembly and stretch in the introducer sheath.During functional testing, the ruby coil lp was unable to be advanced from its returned position due to the kinks in the pusher assembly.Further evaluation of the device revealed an additional pusher assembly kink.This damage was likely incidental to the complaint and may have occurred during packaging for the return.Penumbra coils 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.Section h.Box 6.Conclusions code 1: 4316 - the investigation findings do not lead to a clear conclusion about the root cause of the ruby coil lp not being able to advance at all past its initial position within its introducer sheath.This report is associated with mfr report number: 3005168196-2021-00905.

• Brand Name: RUBY COIL LP
• Common Device Name: HCG, KRD
• Manufacturer (Section D): PENUMBRA, INC.; one penumbra place; alameda CA 94502
• MDR Report Key: 11747034
• Report Number: 3005168196-2021-00904
• Device Sequence Number: 4319004
• Product Code: HCG
• UDI-Device Identifier: 00815948021761
• UDI-Public: 00815948021761
• Combination Product (Y/N): Y
• Initial Reporter State: NY
• Initial Reporter Country: US
• PMA/510(K) Number: K192955
• 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): 04/02/2021
• 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: 12/03/2025
• Device Model Number: RBYLP0210
• Device Catalogue Number: RBYLP0210
• Device Lot Number: F102506
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/20/2021
• Was the Report Sent to FDA?: Yes
• Date Report to Manufacturer: 01/10/2005
• Initial Date Received by Manufacturer: 04/02/2021
• Supplement Date Received by Manufacturer: 05/06/2021
• Initial Report FDA Received Date: 04/29/2021
• Supplement Report FDA Received Date: 06/02/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 65 YR
• Date Report Sent to FDA: 01/01/2005