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

Model Number RBYLP0304

Device Problems Failure to Fold (1255); Failure to Advance (2524); Physical Resistance/Sticking (4012)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 11/10/2021

Event Type  malfunction  

Event Description

The patient was undergoing a coil embolization procedure using ruby coil lps and a microcatheter.During the procedure, while attempting to advance the ruby coil lp to the target vessel, the physician encountered resistance and the ruby coil lp would not fully exit the microcatheter and would not take its intended shape.Therefore, the ruby coil lp was removed.The procedure was completed using another ruby coil lp and the same microcatheter.There was no report of an adverse effect to the patient.

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.

• Brand Name: RUBY COIL LP
• Type of Device: 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: 12927338
• MDR Text Key: 284687352
• Report Number: 3005168196-2021-02742
• Device Sequence Number: 1
• Product Code: HCG
• UDI-Device Identifier: 00815948021778
• UDI-Public: 00815948021778
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K192955
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 01/01/2005,12/03/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/03/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: RBYLP0304
• Device Catalogue Number: RBYLP0304
• Device Lot Number: F94789
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 01/01/2005
• Date Report to Manufacturer: 01/10/2005
• Date Manufacturer Received: 11/10/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 12/09/2019
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1