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

Catalog Number RBYLP0210

Device Problems Physical Resistance/Sticking (4012); Premature Separation (4045)

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

Event Date 02/13/2024

Event Type  malfunction  

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.

Event Description

The patient was undergoing a coil embolization procedure in the gastroduodenal artery (gda) using ruby coil lps and a non-penumbra microcatheter.During the procedure, after advancing the ruby coil lp into the target location, the physician decided to retract the coil to reposition the microcatheter.However, while retracting the ruby coil lp, the physician experienced resistance and the ruby coil lp unintentionally detached inside the microcatheter.Therefore, the microcatheter containing the detached ruby coil lp was removed.The procedure was completed using a new ruby coil lp and a new microcatheter.There was no report of an adverse effect to the patient.

• 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: 18866785
• MDR Text Key: 337754125
• Report Number: 3005168196-2024-00077
• Device Sequence Number: 1
• Product Code: HCG
• UDI-Device Identifier: 00815948025998
• UDI-Public: 815948025998
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K230284
• 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: 01/01/2005,03/08/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/08/2024
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: RBYLP0210
• Device Lot Number: F00008829
• 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: 02/13/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/06/2023
• 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