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

Catalog Number RBY2C1260

Device Problems Bent (1059); Device Handling Problem (3265)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 04/10/2017

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: 3005168196-2017-00709.The hospital disposed of the device.

Event Description

The patient was undergoing a coil embolization procedure treating a fistula using ruby coils.During the procedure, the physician successfully deployed and detached four ruby coils in the fistula using a lantern delivery microcatheter (lantern).Upon attempting to advance a new ruby coil into the lantern, the hospital technician inadvertently bent the ruby coil pusher assembly; therefore it was removed.The physician then successfully deployed and detached additional coils.Upon attempting to advance another ruby coil through the lantern, the physician experienced resistance and the ruby coil was unable to advance past the friction lock of the introducer sheath; therefore, it was removed.The procedure was completed using the same lantern and additional ruby coils.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: 6555783
• MDR Text Key: 74843008
• Report Number: 3005168196-2017-00708
• Device Sequence Number: 1
• Product Code: HCG
• UDI-Device Identifier: 00814548013022
• UDI-Public: 00814548013022
• 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: 04/10/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/09/2017
• Is this a Product Problem Report?: Yes
• Device Operator: Physician
• Device Catalogue Number: RBY2C1260
• Device Lot Number: F69336
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/10/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/16/2016
• 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: 82 YR