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

Device Problems Mechanical Jam (2983); Device Handling Problem (3265)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 12/27/2017

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 product lot number was not provided, therefore, the manufacturing records could not be reviewed.The hospital disposed of the device.

Event Description

The patient was undergoing a coil embolization procedure in the hypogastric artery using ruby coils.During the procedure, the physician deployed and detached the initials ruby coils in the target vessel using a lantern delivery microcatheter (lantern).While attempting to advance the last ruby coil through the lantern, the physician inadvertently pulled the lantern back into the base catheter and consequently, the ruby coil was advanced outside the lantern and inside the base catheter.Therefore, the ruby coil became stuck inside the base catheter.The physician removed the base catheter, the lantern and the ruby coil and ended the procedure at that point.There was no noted issue or damage with the lantern.In addition, 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: 7208102
• MDR Text Key: 98172374
• Report Number: 3005168196-2018-00193
• Device Sequence Number: 1
• Product Code: HCG
• 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: 12/28/2017

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
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 12/28/2017
• Initial Date FDA Received: 01/19/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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