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

Catalog Number	RBY2C0435
Medical Device Problem Codes	Physical Resistance/Sticking (4012); Premature Separation (4045)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	01/09/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The device has been returned and the investigation results are pending.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 gastroduodenal artery (gda) using ruby coils and pod packing coils (podjs).During the procedure, the physician gained access through the patient¿s right femoral artery.The physician then felt resistance while advancing a ruby coil out of the tip of a lantern delivery microcatheter (lantern) and, therefore, the physician retracted the coil.While retracting, the physician felt resistance and the ruby coil unintentionally detached.The physician attempted to place the ruby coil by advancing it with the pusher assembly but was unable to.The physician then attempted to remove the microcatheter with the ruby coil inside, however only the nitinol wire came out with the lantern.The physician then used a snare device to remove the rest of the ruby coil.It was reported that the physician thought that the ruby coil might have been too large for the target location, causing resistance.The physician then punctured the left femoral artery and successfully placed a ruby coil in the target location using the same lantern.The physician then felt resistance while advancing a podj out of the tip of the lantern and, therefore, the physician retracted the podj.While retracting, the physician felt resistance and the podj unintentionally detached within the lantern.Therefore, the lantern was removed with the podj inside.The procedure was then completed using a new podj and the same lantern.There was no report of an adverse effect to the patient.
Additional Manufacturer Narrative
Results: the pet lock was intact on the proximal end of the pusher assembly.The embolization coil stretch resistant wire (sr wire) was fractured and embolization coil was unraveled.Proximal constraint sphere was within the distal detachment tip (ddt).Conclusions: evaluation of the returned ruby coil revealed that the embolization coil was detached due to a fracture of the sr wire.If the embolization coil is forcefully retracted against resistance, the sr wire may fracture and allow the coil to become unraveled.The complaint stated the coil may have been too large for the target anatomy.This likely contributed to the resistance experienced during the procedure.Further evaluation revealed the embolization coil was unraveled.This is likely a result of the snare process after the sr wire became fractured and subsequent handling after the procedure.Evaluation of the returned podj revealed that the embolization coil was detached from its pusher assembly, the pet lock was intact, and the embolization coil was not broken.The pull wire was out of the capture feature of the ddt and extended distally.Retracting the pusher assembly against resistance may cause the polymer section of the pusher assembly to elongate.If the pusher assembly elongates past the reach of the pull wire, the constraint sphere may release from the ddt and allow the pre-tension of the pull wire to relax causing the pull wire to extend distally.Further evaluation revealed some offset coil winds on the embolization coil.These offset coil winds were likely incidental to the reported failure.The lantern identified in the complaint was not returned for evaluation.The root cause of the initial 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.

• Brand Name: RUBY COIL
• Common Device Name: HCG, KRD
• Manufacturer (Section D): PENUMBRA, INC.; one penumbra place; alameda CA 94502
• MDR Report Key: 8319128
• Report Number: 3005168196-2019-00212
• Device Sequence Number: 1318550
• Product Code: HCG
• UDI-Device Identifier: 00814548012889
• UDI-Public: 00814548012889
• Combination Product (Y/N): Y
• Initial Reporter Country: GM
• PMA/510(K) Number: K141134
• 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): 01/09/2019
• 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 Expiration Date: 11/18/2025
• Device Catalogue Number: RBY2C0435
• Device Lot Number: F80632
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/29/2019
• Was the Report Sent to FDA?: Yes
• Date Report to Manufacturer: 01/10/2005
• Initial Date Received by Manufacturer: 01/09/2019
• Supplement Date Received by Manufacturer: 03/05/2019
• Initial Report FDA Received Date: 02/07/2019
• Supplement Report FDA Received Date: 03/29/2019
• 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: 54 YR
• Date Report Sent to FDA: 01/01/2005