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

Catalog Number	RBY2C0420
Medical Device Problem Code	Failure to Advance (2524)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	07/14/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Results: the pet lock was intact on the proximal end of the ruby coil pusher assembly.The pusher assembly was fractured approximately 72.0 cm from the proximal end and kinked in multiple locations.The embolization coil was detached from the pusher assembly.Conclusion: evaluation of the returned device revealed the pusher assembly was fractured and the embolization coil was detached.Fracture of the pusher assembly may allow the distal end of the pull wire to retract out of the distal detachment tip (ddt), which will cause the embolization coil to detach.Since the ruby coil was reportedly removed from the procedure with no mention of pusher assembly fracture or detachment, the pusher assembly fracture, as well as the subsequent detachment of the embolization coil, were likely incidental and likely occurred after successful removal of the ruby coil from the procedure.The kinks were also likely incidental and may have occurred during packaging for return to penumbra.Since the pusher assembly was fractured and the embolization coil was detached, the root cause of the inability to advance could not be determined.The ruby coil embolization coil and lantern mentioned in the complaint were not returned for evaluation.Penumbra coils and catheters 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 number: 3005168196-2017-01356.
Event or Problem Description
The patient was undergoing a coil embolization procedure using ruby coils and a lantern delivery microcatheter (lantern).During the procedure, the physician deployed and detached two ruby coils into the target vessel using the lantern.While attempting to advance another ruby coil, the physician was unable to advance the coil out of its introducer sheath and into the hub of the lantern.The physician then made multiple attempts to adjust the lantern and ruby coil but was still unable to advance the coil out of its introducer sheath.Therefore, both the ruby coil and lantern were removed.It was reported that the ruby coil was able to be advanced out of its introducer sheath when not inserted into the hub of the lantern.The procedure was then completed using a new ruby coil and a new lantern.There was no report of an adverse effect to the patient.

• Brand Name: RUBY COIL
• Common Device Name: HCG,KRD
• Manufacturer (Section D): PENUMBRA, INC.; one penumbra place; alameda CA 94502
• MDR Report Key: 6775360
• Report Number: 3005168196-2017-01355
• Device Sequence Number: 831901
• Product Code: HCG
• UDI-Device Identifier: 00814548012865
• UDI-Public: 00814548012865
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: K120330
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 07/14/2017

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: Physician
• Device Expiration Date: 10/31/2024
• Device Catalogue Number: RBY2C0420
• Device Lot Number: F72619
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/20/2017
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/14/2017
• Initial Report FDA Received Date: 08/08/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 54 YR
• Patient Weight: 82