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

Model Number RBYLP0102

Device Problem Break (1069)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 06/02/2020

Event Type  malfunction  

Manufacturer Narrative

The product was not returned for evaluation.Without the return of the device, an investigation cannot be performed.The product lot number was not provided, therefore, the manufacturing records could not be reviewed.

Event Description

The patient was undergoing a coil embolization procedure in a branch of the ileocolic artery using a ruby coil lp and a non-penumbra microcatheter.During the procedure, the physician advanced the ruby coil lp into the target vessel using the microcatheter.While forming the ruby coil in the target vessel, the physician was not satisfied with the way the ruby coil lp was forming; therefore, the physician decided to remove the ruby coil lp and try a larger coil.While re-sheathing the ruby coil lp, the physician had difficulty and subsequently, the ruby coil lp detached from the pusher assembly while being pulled all the way back into its introducer sheath.The procedure was completed using another coil and the same microcatheter.There was no report of an adverse effect to the patient.

• 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: 10203204
• MDR Text Key: 196698494
• Report Number: 3005168196-2020-00838
• Device Sequence Number: 1
• Product Code: HCG
• UDI-Device Identifier: 00815948021723
• UDI-Public: 00815948021723
• Combination Product (y/n): Y
• Reporter Country Code: US
• PMA/PMN Number: K192955
• 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
• Report Date: 01/01/2005,06/03/2020

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 Model Number: RBYLP0102
• Device Catalogue Number: RBYLP0102
• 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: 06/03/2020
• Initial Date FDA Received: 06/26/2020
• 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: 69 YR
• Patient Weight: 91