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

Model Number	RBYLP0202
Medical Device Problem Codes	Failure to Advance (2524); Material Deformation (2976)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/06/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Evaluation of the returned ruby coil lp confirmed the pusher assembly bent but could not confirm the reported coil advancement issue.Evaluation revealed that the device was returned advanced from its initial position and partially out of the introducer sheath.During functional testing, the ruby coil lp was re-sheathed within its initial position inside the introducer sheath then the device was able to advance out of the introducer sheath with resistance due to the kinks in the pusher assembly.The kinks in the pusher assembly may likely occur due to forcefully mishandle the device during advancement.Further evaluation of the device revealed offset coil winds.This damage was likely incidental to the complaint.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.This report is associated with mfr report number: 3005168196-2021-02441.
Event or Problem Description
The patient was undergoing a coil embolization procedure in the cystic artery using ruby coil lps.During the procedure, a ruby coil lp would not advance at all past its initial position within its introducer sheath.Subsequently, the hospital technologist bent the pusher assembly of the ruby coil lp.Therefore, the ruby coil lp was removed.Next, the same issue occurred with another ruby coil lp.Therefore, the ruby coil lp was also removed.The procedure was completed using a new packing coil lp.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
• MDR Report Key: 12727988
• Report Number: 3005168196-2021-02442
• Device Sequence Number: 13800061
• Product Code: HCG
• UDI-Device Identifier: 00815948021747
• UDI-Public: 00815948021747
• Combination Product (Y/N): Y
• Initial Reporter State: CO
• 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
• Report Date (Section B): 11/01/2021
• 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: 05/24/2026
• Device Model Number: RBYLP0202
• Device Catalogue Number: RBYLP0202
• Device Lot Number: F106573
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/15/2021
• 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: 10/06/2021
• Initial Report FDA Received Date: 11/01/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Date Report Sent to FDA: 01/01/2005