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

Device Problems Difficult or Delayed Positioning (1157); Structural Problem (2506); Physical Resistance (2578)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 06/20/2016

Event Type  malfunction  

Manufacturer Narrative

(b)(4).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 left subclavian artery using ruby coils.During the procedure, the physician placed another manufacturer's microcatheter at the ostium of the patient's left subclavian artery and then advanced a ruby coil through it.While the ruby coil was being deployed, it started to prolapse on itself.The physician then attempted to retract the ruby coil in order to re-position it; however, while retracting the coil, the physician experienced friction and subsequently, the coil unintentionally detached with over half of the coil remaining in the microcatheter.Therefore, the microcatheter containing the detached ruby coil was removed and the procedure was completed using additional ruby coils.It should be noted that the physician did not use a rotating hemostasis valve (rhv) and did not have continuous flush throughout the procedure.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: kathleen kidd ; one penumbra place; alameda, CA 94502 ; 5107483200
• MDR Report Key: 5807068
• MDR Text Key: 49946767
• Report Number: 3005168196-2016-01025
• 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
• Type of Report: Initial
• Report Date: 06/20/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/19/2016
• 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?: No
• Date Manufacturer Received: 06/20/2016
• 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
• Patient Age: 73 YR