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

Catalog Number RH1

Device Problems Mechanical Problem (1384); Device Operates Differently Than Expected (2913)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 05/31/2018

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: 3005168196-2018-01285, 3005168196-2018-01286, 3005168196-2018-01287, 3005168196-2018-01288.The hospital discarded the device.

Event Description

The patient was undergoing a coil embolization procedure in the aorta using ruby coils and a ruby coil detachment handle (handle).It was noted that the patient's anatomy was tortuous.During the procedure, the physician advanced a ruby coil into the target vessel using a lantern delivery microcatheter (lantern) and used a handle to detach it; however, the ruby coil failed to detach.Therefore, the physician manually detached the ruby coil.It was reported the same issue occurred with two additional ruby coils.While attempting to advance a new ruby coil through the lantern, the physician experienced resistance and the ruby coil would not advance; therefore, it was removed.The procedure was completed using another ruby coil, a second handle and the same lantern.There was no report of an 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 ; 5107483200
• MDR Report Key: 7646330
• MDR Text Key: 112892814
• Report Number: 3005168196-2018-01284
• Device Sequence Number: 1
• Product Code: HCG
• UDI-Device Identifier: 00814548013268
• UDI-Public: 00814548013268
• Combination Product (y/n): N
• 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: Physician
• Type of Report: Initial
• Report Date: 05/31/2018

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
• Device Operator: Physician
• Device Expiration Date: 11/27/2020
• Device Catalogue Number: RH1
• Device Lot Number: F80714
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 05/31/2018
• Initial Date FDA Received: 06/28/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 11/28/2017
• 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
• Patient Age: 83 YR
• Patient Weight: 64