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

Catalog Number RH1

Device Problem Separation Problem (4043)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 10/03/2019

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.This report is associated with mfr report numbers: 3005168196-2019-02031.

Event Description

The patient was undergoing a coil embolization procedure using ruby coils and a ruby coil detachment handle (handle).During the procedure, the physician advanced a ruby coil into the target vessel using a lantern delivery microcatheter (lantern) and attempted to detach it using handle; however, the ruby coil failed to detach.Therefore, the ruby coil was removed, and the procedure was completed using additional ruby coils and the same handle.There was no adverse effect to the patient.

• Brand Name: RUBY COIL DETACHMENT HANDLE
• 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 ; 510748-320
• MDR Report Key: 9269626
• MDR Text Key: 164808730
• Report Number: 3005168196-2019-02032
• Device Sequence Number: 1
• Product Code: HCG
• UDI-Device Identifier: 00814548013268
• UDI-Public: 00814548013268
• Combination Product (y/n): Y
• Reporter Country Code: US
• PMA/PMN Number: K120330
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 01/01/2005,10/03/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/01/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: RH1
• 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: 10/03/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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