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

Model Number	RBY4C1650-A
Medical Device Problem Codes	Failure to Advance (2524); Physical Resistance/Sticking (4012)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	01/02/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
This device is available for return.A follow up mdr will be submitted upon completion of the device investigation.This report is associated with mfr report numbers: 3005168196-2020-00094, 3005168196-2020-00095, 3005168196-2020-00097.
Event or Problem Description
The patient was undergoing a coil embolization procedure to treat a pulmonary arteriovenous malformation (avm) using a lantern delivery microcatheter (lantern), ruby coils and non-penumbra diagnostic catheter.During the procedure, the physician placed the diagnostic catheter and the lantern in the target vessel.While attempting to advance a ruby coil through the lantern, the physician experienced resistance and the ruby coil would not advance; therefore, it was removed.The physician then attempted to advance two additional ruby coils through the lantern, however, the same issue occurred.Therefore, the ruby coils were removed.The physician then removed the diagnostic catheter and lantern.The procedure was completed using additional ruby coils and a new lantern.There was no report of an adverse effect to the patient.
Additional Manufacturer Narrative
Results: the pet lock was intact.The proximal constraint sphere was attached to the pusher assembly.The proximal portion of the sr component was exposed due to the embolization coil winds being compressed distally.Part of the embolization coil was returned outside of its protective sheath.The embolization coil had offset coil winds along its length.Conclusions: evaluation of the returned lantern revealed a fully functional device.A demonstration coil was able to advance through the lantern without issue.Evaluation of the returned ruby coil revealed offset coil winds along the length of the embolization coil.The embolization coils were compressed distally.The proximal constraint sphere was attached to the pusher assembly.If the device is forcefully advanced against resistance, damage such as offset coil winds may occur.If damaged coil winds are retracted against resistance, they may begin to compress and cause additional damage.Root cause of the initial resistance during the case could not be determined.Penumbra catheters and 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.This report is associated with mfr report numbers: 3005168196-2020-00094; 3005168196-2020-00095; 3005168196-2020-00097.

• Brand Name: RUBY COIL
• Common Device Name: HCG, KRD
• Manufacturer (Section D): PENUMBRA, INC.; one penumbra place; alameda CA 94502
• MDR Report Key: 9628942
• Report Number: 3005168196-2020-00096
• Device Sequence Number: 19560189
• Product Code: HCG
• UDI-Device Identifier: 00814548013244
• UDI-Public: 00814548013244
• Combination Product (Y/N): Y
• Initial Reporter Country: NL
• 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: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 01/03/2020
• 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 Model Number: RBY4C1650-A
• Device Catalogue Number: RBY4C1650
• Device Lot Number: F89760
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/26/2020
• Was the Report Sent to FDA?: Yes
• Date Report to Manufacturer: 01/10/2005
• Initial Date Received by Manufacturer: 01/03/2020
• Supplement Date Received by Manufacturer: 03/11/2020
• Initial Report FDA Received Date: 01/24/2020
• Supplement Report FDA Received Date: 04/01/2020
• 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