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

Catalog Number	RBY2C0320
Medical Device Problem Codes	Break (1069); Physical Resistance/Sticking (4012)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/05/2023
Type of Reportable Event	Malfunction
Event or Problem Description
The patient was undergoing a coil embolization procedure to treat an endoleak in the iliolumbar artery using a ruby coil, an embolic glue, and a non-penumbra microcatheter.It should be noted that the patient''s anatomy was tortuous.During the procedure, the physician implanted the embolic glue and attempted to trap the glue using a ruby coil.While advancing the ruby coil into the target location, the physician did not like the way the ruby coil was packing attempted to retract it out of the glue for repositioning; however, resistance was encountered.It was reported that the ruby coil would not retract completely into the microcatheter.While attempting to remove the ruby coil using a snare device, the coil fractured at the distal end and only part of the ruby coil was removed from the patient.The remaining part of the ruby coil was left in the target vessel.The procedure ended at this point.There was no report of an adverse effect to the patient.
Additional Manufacturer Narrative
Evaluation of the returned ruby coil confirmed that the coil was detached from its pusher assembly.The embolization coil was fractured and unraveled.Evaluation revealed that the proximal constraint sphere was present on the embolization coil, and the stretch resistant (sr) component was fractured.If the device is retracted against resistance, damage such as this may occur.The complaint reported that the embolic glue was implanted during the procedure and had interacted with the ruby coil.This likely contributed to the resistance and the embolization coil detachment during retraction of the ruby coil.Some of the damage may have occurred during removal of the embolization coil using the snare during the procedure.The pusher assembly was not returned for evaluation.Penumbra coils are visually inspected during in-process inspection and during quality inspection after manufacturing.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
• Common Device Name: 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: 17075926
• Report Number: 3005168196-2023-00271
• Device Sequence Number: 6673251
• Product Code: HCG
• UDI-Device Identifier: 00814548018560
• UDI-Public: 814548018560
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: K173614
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2023
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 06/06/2023
• 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: Health Professional
• Device Catalogue Number: RBY2C0320
• Device Lot Number: F00002249
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/18/2023
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report to Manufacturer: 01/10/2005
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/09/2023
• Initial Report FDA Received Date: 06/06/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/26/2022
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Age: 79 YR
• Patient Sex: Male
• Date Report Sent to FDA: 01/01/2005