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

Model Number	RBY2C0612-A
Medical Device Problem Codes	Detachment Of Device Component (1104); Mechanical Jam (2983)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	01/25/2018
Type of Reportable Event	Malfunction
Additional 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 manufacturing records for this lot were reviewed and did not reveal any outstanding discrepancies, design, or quality concerns.
Event or Problem Description
The patient was undergoing a coil embolization procedure to treat portal hypertension and esophageal varices using a ruby coil.During the procedure, following the placement of the stent, a 5f glide catheter was delivered over a guidewire and a non-penumbra coil was deployed in an attempt to embolize the varices.The physician then delivered a non-penumbra microcatheter through the glide catheter and attempted to use a ruby coil.While advancing the coil through the microcatheter, the ruby coil unintentionally detached inside the microcatheter.In an attempt to remove the detached coil, the physician pulled the microcatheter through the glide catheter and the coil became lodged in the glide catheter.Numerous attempts were made to flush the coil out the glide catheter and into the varices; however, the coil would not advance.The physician then delivered a guide wire through the glide catheter and attempted to push the coil out of the glide catheter; however, the coil would still not advance.Therefore, the diagnostic catheter was removed with the coil and the procedure was completed.There was no report of an adverse effect to the patient.
Event or Problem Description
The patient was undergoing a coil embolization procedure to treat portal hypertension and esophageal varices using a ruby coil.During the procedure, following the placement of the stent, a 5f glide catheter was delivered over a guidewire and a non-penumbra coil was deployed in an attempt to embolize the varices.The physician then delivered a non-penumbra microcatheter through the glide catheter and attempted to use a ruby coil.While advancing the coil through the microcatheter, the physician did not mention resistance; however, the ruby coil unintentionally detached inside the microcatheter.In an attempt to remove the detached coil, the physician pulled the microcatheter through the glide catheter and the coil became lodged in the glide catheter.Numerous attempts were made to flush the coil out the glide catheter and into the varices; however, the coil would not advance.The physician then delivered a guide wire through the glide catheter and attempted to push the coil out of the glide catheter; however, the coil would still not advance.Therefore, the diagnostic catheter was removed with the coil and the procedure was completed.There was no report of an adverse effect to the patient.

• Brand Name: RUBY COIL
• Common Device Name: HCG, KRD
• Manufacturer (Section D): PENUMBRA, INC.; one penumbra place; alameda CA 94502
• MDR Report Key: 7290432
• Report Number: 3005168196-2018-00395
• Device Sequence Number: 16642658
• Product Code: HCG
• UDI-Device Identifier: 00814548012926
• UDI-Public: 00814548012926
• Combination Product (Y/N): Y
• Initial Reporter State: NY
• Initial Reporter Country: US
• PMA/510(K) Number: K120330
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 01/25/2018
• Report Date (Section F): 01/01/2005

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
• Operator of Device: Physician
• Device Expiration Date: 03/21/2024
• Device Model Number: RBY2C0612-A
• Device Catalogue Number: RBY2C0612
• Device Lot Number: F68610
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Date Report to Manufacturer: 01/10/2005
• Initial Date Received by Manufacturer: 01/25/2018
• Supplement Date Received by Manufacturer: 01/14/2005
• Initial Report FDA Received Date: 02/22/2018
• Supplement Report FDA Received Date: 07/15/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Date Report Sent to FDA: 01/01/2005