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

Model Number	RBY2C1460-A
Medical Device Problem Codes	Unraveled Material (1664); Physical Resistance/Sticking (4012); Premature Separation (4045)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	11/30/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
This device is available for return.A follow up mdr will be submitted upon completion of the device investigation.
Event or Problem Description
The patient was undergoing a coil embolization procedure in the left testicular vein using ruby coils and a non-penumbra microcatheter.During the procedure, the physician successfully placed one ruby coil into the target vessel using the microcatheter.While advancing a second ruby coil, the physician experienced resistance after the majority of the ruby coil had exited the microcatheter.The physician reported that there was ¿disruption¿ with the distal marker on the pusher assembly (between the end of the coil and the distal marker on the pusher assembly).It was also reported that it was creating a ¿z¿ shape or sliding over itself.After pulling back on the pusher assembly, half of the ruby coil remained in the microcatheter.The physician then flushed the microcatheter, but the ruby coil failed to advance.While withdrawing the microcatheter, the physician noticed that the ruby coil was unraveling and following the path of the microcatheter.Since part of the ruby coil remained in the patient, the physician performed a computed tomography (ct) and noticed radiolucent filament extending into the atrium of the heart.The ruby coil was removed using a snare.It was reported that the patient underwent two other cts and two additional passes with a snare device from the iliac veins to the pulmonary arteries to remove all the remaining filaments, causing additional radiation and stress.The procedure was ended at this point.
Additional Manufacturer Narrative
Results: the embolization coil¿s stretch resistant wire (sr wire) was fractured, and the embolization coil was unraveled.Conclusions: evaluation of the returned ruby coil embolization coil revealed that the sr wire was fractured, and the embolization coil was unraveled.If the device is forcefully retracted against resistance, damage such as a fractured sr wire may occur.If this occurs, the embolization coil can become detached and unravel.No other components of the ruby coil and no other devices associated with the complaint were returned for evaluation; therefore, the root cause of resistance could not be determined.Penumbra coils are 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
• MDR Report Key: 9513301
• Report Number: 3005168196-2019-02412
• Device Sequence Number: 3542097
• Product Code: HCG
• UDI-Device Identifier: 00814548013046
• UDI-Public: 00814548013046
• Combination Product (Y/N): Y
• Initial Reporter Country: UK
• PMA/510(K) Number: K120330
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 12/03/2019
• 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?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: RBY2C1460-A
• Device Catalogue Number: RBY2C1460
• Device Lot Number: F90320
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/21/2020
• Was the Report Sent to FDA?: Yes
• Date Report to Manufacturer: 01/10/2005
• Initial Date Received by Manufacturer: 12/03/2019
• Supplement Date Received by Manufacturer: 01/27/2020
• Initial Report FDA Received Date: 12/23/2019
• Supplement Report FDA Received Date: 01/31/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 30 YR
• Date Report Sent to FDA: 01/01/2005