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

Model Number	RBYLP0210
Medical Device Problem Codes	Failure to Advance (2524); Premature Separation (4045)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/21/2021
Type of Reportable Event	Malfunction
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: 3005168196-2021-01045, 3005168196-2021-01046, 3005168196-2021-01048.
Event or Problem Description
The patient was undergoing a coil embolization procedure in a branch off posterior tibial artery using ruby coil lps and non-penumbra microcatheter.During the procedure, a ruby coil lp was unable to advance past the friction lock within the introducer sheath.The physician attempted to modify hand placement with the ruby coil lp to disengage the friction lock to troubleshoot; however, while troubleshooting, the ruby coil lp detached from the pusher assembly before entering the microcatheter.Therefore, the ruby coil lp was removed.Subsequently, the physician was unable to advance the next three ruby coil lps past the friction lock.It was also reported while attempting to use the same troubleshooting technique, all three ruby coil lps detached from the pusher assembly within the introducer sheath before entering the microcatheter.Therefore, all three ruby coil lps was removed.The procedure was completed using new ruby coils, other coils, and the same microcatheter.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: 11827302
• Report Number: 3005168196-2021-01047
• Device Sequence Number: 16408646
• Product Code: HCG
• UDI-Device Identifier: 00815948021761
• UDI-Public: 00815948021761
• Combination Product (Y/N): Y
• Initial Reporter State: ME
• 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): 04/21/2021
• 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: 06/17/2025
• Device Model Number: RBYLP0210
• Device Catalogue Number: RBYLP0210
• Device Lot Number: F98411
• 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: 04/21/2021
• Initial Report FDA Received Date: 05/14/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 27 YR
• Date Report Sent to FDA: 01/01/2005