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

Catalog Number RBY4C0630

Device Problems Material Frayed (1262); Split (2537); Device Dislodged or Dislocated (2923)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 10/11/2017

Event Type  Injury  

Manufacturer Narrative

The product was disposed of by the hospital and is no longer available for return.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.

Event Description

It was reported that a ruby coil split and frayed.It is unknown if there was patient involvement.Please note that the manufacturer has requested additional information from the customer regarding the details of the event; however, no additional information has been obtained.

Manufacturer Narrative

Please note that the following sections are being updated based on additional information received on 11 dec 2017: adverse event and/ or product problem: outcomes attributed to adverse event, describe event or problem, initial reporter also sent report to fda, report source, type of reportable event, evaluation codes, device and patient codes.

Event Description

Updated event description: the patient was undergoing a coil embolization procedure in the hepatic artery using ruby coils.During the procedure, a ruby coil did not deploy properly; it was reported that the coil split and frayed.Therefore, the physician snared the ruby coil but it dislodged into the soft tissue adjacent to the blood vessel in the right groin.It is unknown how the procedure was completed or if there was 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: 7014782
• MDR Text Key: 92637505
• Report Number: 3005168196-2017-01942
• 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: Physician
• Type of Report: Initial,Followup
• Report Date: 10/12/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: RBY4C0630
• Device Lot Number: F75490
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 10/12/2017
• Initial Date FDA Received: 11/09/2017
• Supplement Dates Manufacturer Received: 12/11/2017
• Supplement Dates FDA Received: 01/10/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/10/2017
• 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 Outcome(s): Required Intervention