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

Catalog Number	RBY4C1240-A
Medical Device Problem Codes	Detachment Of Device Component (1104); Fracture (1260); Physical Resistance (2578)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	06/07/2016
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The 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 using ruby coils.During the procedure, the physician delivered three ruby coils in the target vessel using a px slim delivery microcatheter (px slim).While advancing a new ruby coil in the target vessel using the px slim, the physician experienced resistance.When the ruby coil was almost deployed in the target vessel, it unintentionally detached with part of it in the px slim and part in the aneurysm.After a failed attempt to withdraw the diagnostic catheter in order to retrieve the detached ruby coil, the physician decided to use a wire.The physician pushed the detached ruby coil through the px slim using the wire; however, it was unable to remove the detached ruby coil.The physician then decided to remove the px slim; however, while removing the px slim, the ruby coil fractured.There was still part of the ruby coil out of the diagnostic catheter; therefore, the physician attempted to pull it.While pulling the ruby coil, the wire tore off and part of the ruby coil was still in the diagnostic catheter and the other part was in the aneurysm.After several failed attempts to capture the ruby coil using a snare device, the procedure was aborted.The ruby coil was left in the patient with part of it in the aneurysm and the other part in the splenic artery.There was no report of an adverse effect to the patient.
Additional Manufacturer Narrative
Result: the pet lock was intact on the proximal end of the ruby coil pusher assembly; the pusher assembly was kinked approximately 5.0 and 8.0 cm from the proximal end; the stretch resistant wire (sr wire) was fractured and the proximal constraint sphere was not present.Conclusion: evaluation of the returned device revealed that the pet lock was intact, and the embolization coil was detached from the pusher assembly.This likely occurred due to improper handling during use.If excessive force is used during withdrawal it is likely that the polymer portion of the ruby coil will elongate, effectively extending the distal detachment tip (ddt) beyond the reach of the pull wire.This will allow the proximal constraint sphere of the embolization coil to become detached from the pusher assembly.Evaluation of the embolization coil revealed that the sr wire was fractured.Attempting to remove the px slim delivery microcatheter (px slim) through the diagnostic catheter with the embolization coil hanging out of the px slim may have caused the embolization coil to become caught on the diagnostic catheter and subsequently fracture.Further evaluation revealed that the ruby coil pusher assembly was kinked.These kinks were likely incidental and may have occurred during packaging the device for returned.The px slim mentioned in the complaint was not returned for evaluation.Therefore, the root cause of the resistance experienced during the procedure could not be determined.All 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: 5761686
• Report Number: 3005168196-2016-00939
• Device Sequence Number: 3620
• Product Code: HCG
• UDI-Device Identifier: 00814548013237
• UDI-Public: 00814548013237
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• 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): 06/07/2016

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: Physician
• Device Expiration Date: 11/16/2023
• Device Catalogue Number: RBY4C1240-A
• Device Lot Number: F66565
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/26/2016
• Type of Report(Section G): FDA Requested
• Initial Date Received by Manufacturer: 06/07/2016
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 06/30/2016
• Supplement Report FDA Received Date: 09/16/2016
• 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: 55 YR