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

Model Number RBY2C0435-A

Device Problems Bent (1059); Device Damaged Prior to Use (2284); Out-Of-Box Failure (2311)

Patient Problem No Patient Involvement (2645)

Event Date 01/17/2018

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 number: 3005168196-2018-00332, 3005168196-2018-00334.

Event Description

The patient was undergoing a coil embolization in the gastroduodenal artery (gda) and left gastric artery using ruby coils.During the procedure, prior to use, the hospital technologist noticed that a ruby coil pusher assembly was bent upon removal from the dispenser hoop; therefore, it was set aside.While attempting to advance a second ruby coil through a lantern delivery microcatheter (lantern), the physician experienced resistance and the ruby coil would not advance out of the tip of the lantern; therefore, the lantern and the ruby coil were removed together as a system.The ruby coil then became unraveled after removal from the lantern outside the patient's body.It was was reported that the lantern was clogged off and the physician was unable to pass a guide wire through the lantern.The procedure was successfully completed using a new lantern and ruby coils.There was no report of an adverse effect to the patient.

Manufacturer Narrative

This report is associated with mfr report number: 3005168196-2018-00332 and 3005168196-2018-00334.

• Brand Name: RUBY COIL
• Type of Device: HCG, KRD
• Manufacturer (Section D): PENUMBRA, INC.; one penumbra place; alameda CA 94502
• MDR Report Key: 7265213
• MDR Text Key: 100019108
• Report Number: 3005168196-2018-00333
• Device Sequence Number: 1
• Product Code: HCG
• UDI-Device Identifier: 00814548012889
• UDI-Public: 00814548012889
• Combination Product (y/n): Y
• PMA/PMN Number: K120330
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup
• Report Date: 01/01/2005,01/17/2018

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: Radiologic Technologist
• Device Expiration Date: 03/21/2024
• Device Model Number: RBY2C0435-A
• Device Catalogue Number: RBY2C0435
• Device Lot Number: F68607
• Was Device Available for Evaluation?: No
• 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: 01/17/2018
• Initial Date FDA Received: 02/12/2018
• Supplement Dates Manufacturer Received: 01/14/2005
• Supplement Dates FDA Received: 07/09/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 66 YR