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

Catalog Number RBYLP0204

Device Problems Break (1069); Physical Resistance/Sticking (4012)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 08/19/2022

Event Type  malfunction  

Event Description

The patient was undergoing a radioembolization procedure (y90) in the liver using ruby coil lps and a non-penumbra microcatheter.During the procedure, the ruby coil lp would not advance out of its introducer sheath.Therefore, the ruby coil lp was removed.While attempting to use another ruby coil lp, the physician had difficulty advancing the ruby coil lp out of its introducer sheath.Subsequently, while advancing the same ruby coil lp through the microcatheter, the physician and the hospital technologist experienced resistance and the ruby coil lp partially broke in the microcatheter.Therefore, the physician used a hemostat and a syringe and removed the broken ruby coil lp.It was reported that a part of the coil was attached to the pusher assembly.The procedure was completed using non-penumbra coils and the same microcatheter.There was no report of an adverse effect to the patient.

Manufacturer Narrative

This device is available for return.A follow up mdr will be submitted upon completion of the device investigation.

Manufacturer Narrative

Please note that the device associated with this complaint was expected to be returned; however, additional information received from the penumbra sales representative indicated that the device was disposed of and is no longer available for return.Therefore, 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.H3 other text : placeholder.

• Brand Name: RUBY COIL LP
• 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: 15414486
• MDR Text Key: 305191607
• Report Number: 3005168196-2022-00428
• Device Sequence Number: 1
• Product Code: HCG
• UDI-Device Identifier: 00815948021754
• UDI-Public: 815948021754
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K192955
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 01/01/2005,10/28/2022

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: Health Professional
• Device Catalogue Number: RBYLP0204
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 01/01/2005
• Date Report to Manufacturer: 01/10/2005
• Initial Date Manufacturer Received: 08/19/2022
• Initial Date FDA Received: 09/13/2022
• Supplement Dates Manufacturer Received: 10/12/2022
• Supplement Dates FDA Received: 10/29/2022
• 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: 65 YR
• Patient Sex: Female