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

Catalog Number RBY4C0630

Device Problems Bent (1059); Failure to Advance (2524)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 09/05/2017

Event Type  malfunction  

Manufacturer Narrative

The product was not returned for evaluation.Without the return of the device, the reported issue cannot be confirmed and 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: 3005168196-2017-01670, 3005168196-2017-01671.The hospital retained the device for review.

Event Description

The patient was undergoing a coil embolization in the superior mesenteric vein using ruby coils and a lantern delivery microcatheter (lantern).During the procedure, the physician successfully deployed and detached the initial ruby coils in the target vessel using a lantern.While attempting to advance a new ruby coil into the lantern, the physician did not mention resistance; however, the ruby coil pusher assembly became bent upon advancement into the lantern.Therefore, it was removed.While attempting to advance another ruby coil into the target vessel, the physician immediately experienced resistance upon advancing the ruby coil out the lantern.Therefore, the physician decided to withdraw the ruby coil; however, the ruby coil would not withdraw.The physician then withdrew the lantern a couple of millimeters and attempted to advance the ruby coil; however, the ruby coil would not move.The physician then decided to retract the ruby coil; however, upon retraction, the ruby coil unintentionally detached in the patient¿s body.The physician attempted to use a snare device to remove the detached ruby coil; however, the physician was unable to remove the ruby coil and the ruby coil was left in the superior mesenteric vein.The procedure was completed by placing a non-penumbra stent device.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: 6897387
• MDR Text Key: 88393250
• Report Number: 3005168196-2017-01669
• Device Sequence Number: 1
• Product Code: HCG
• UDI-Device Identifier: 00814548013190
• UDI-Public: 00814548013190
• 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: Other Health Care Professional
• Type of Report: Initial
• Report Date: 09/05/2017

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 Catalogue Number: RBY4C0630
• Device Lot Number: F77145
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 09/05/2017
• Initial Date FDA Received: 09/27/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/17/2017
• 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: 70 YR
• Patient Weight: 95