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

Model Number RBY2C3260-A

Device Problems Break (1069); Material Deformation (2976)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 06/23/2020

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: 3005168196-2020-00969, 3005168196-2020-00970, 3005168196-2020-00971.

Event Description

The patient was undergoing a coil embolization in the aorta using ruby coils, pod packing coils (podjs) and a lantern delivery microcatheter (lantern).During the procedure, the physician placed three ruby coils into the target vessel using the lantern.While attempting to insert the next coil, a ruby coil into the lantern, the pusher assembly of the ruby coil kinked.Subsequently, the ruby coil detached within its introducer sheath; therefore, the ruby coil was removed.The physician then placed two ruby coils into the target vessel using the lantern.While attempting to insert a podj into the lantern, the same issue occurred.The pusher assembly of the podj kinked and subsequently, the podj detached within its introducer sheath; therefore, the podj was removed.The physician then placed one podj into the target vessel using the lantern.While attempting to insert a ruby coil into the lantern, the pusher assembly of the ruby coil kinked.Subsequently, the ruby coil detached within its introducer sheath; therefore, the ruby coil was removed.Then, the physician attempted to insert a podj into the lantern; however, the same issue occurred; therefore, the podj was removed.The procedure was completed using a ruby coil and the same lantern.There was no report of an adverse effect to the patient.

• Brand Name: RUBY COIL
• 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: 10290785
• MDR Text Key: 199317225
• Report Number: 3005168196-2020-00968
• Device Sequence Number: 1
• Product Code: HCG
• UDI-Device Identifier: 00814548013107
• UDI-Public: 00814548013107
• Combination Product (y/n): Y
• Reporter Country Code: FR
• PMA/PMN Number: K120330
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 01/01/2005,06/24/2020

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: Health Professional
• Device Model Number: RBY2C3260-A
• Device Catalogue Number: RBY2C3260
• Device Lot Number: F95083
• 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
• Initial Date Manufacturer Received: 06/24/2020
• Initial Date FDA Received: 07/17/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 12/20/2019
• 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
• Patient Age: 89 YR