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

Catalog Number	RBY2C0630
Medical Device Problem Codes	Retraction Problem (1536); Failure to Advance (2524); Physical Resistance (2578)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	04/04/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).Results: the pet lock was intact on the proximal end of the ruby coil¿s pusher assembly.The pusher assembly was kinked in multiple locations.The stretch resistant wire (sr wire) was fractured and the embolization coil was detached from the pusher assembly.Conclusions: evaluation of the first ruby coil revealed that the stretch resistant (sr) wire was fractured and the embolization coil was detached.Fracture of the sr wire typically occurs due to forceful retraction of the ruby coil against resistance, and will allow the embolization coil to detach.Further evaluation revealed that the first ruby coil¿s pusher assembly was kinked in multiple locations.This damage was likely incidental and may have occurred during packaging for return to penumbra.Evaluation of the second ruby coil revealed that the embolization coil had offset coil winds.Offset coil winds typically occur due to forceful advancement of the ruby coil against resistance.After flushing the introducer sheath, the embolization coil became stuck during retraction into the introducer sheath.The embolization coil becoming stuck during functional analysis likely occurred due to the offset coil winds.The root cause of the initial resistance reported while advancing the second ruby coil could not be determined.The lantern mentioned in the complaint was 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: 3005168196-2017-00675.
Event or Problem Description
The patient was undergoing a coil embolization procedure using ruby coils.During the procedure, the physician successfully placed multiple ruby coils into the target vessel using a lantern delivery microcatheter (lantern).While attempting to advance a new ruby coil through the lantern, the physician encountered resistance and decided to retract the coil.However, while the coil was being retracted with slight resistance, it unintentionally detached inside the lantern.Since the coil was partially sticking out of the lantern's hub, the physician was able to pull the coil out of the lantern.Next, the physician attempted to advance a new ruby coil through the same lantern but encountered resistance.The ruby coil was then resheathed and another attempt was made to advance the coil; however, resistance was encountered again.Therefore, the ruby coil was removed and the procedure was completed using additional coils and the same 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: 6539058
• Report Number: 3005168196-2017-00674
• Device Sequence Number: 16551174
• Product Code: HCG
• UDI-Device Identifier: 00814548012940
• UDI-Public: 00814548012940
• Combination Product (Y/N): N
• Initial Reporter State: NY
• 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: Physician
• Type of Report: Initial
• Report Date (Section B): 04/04/2017

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: 09/13/2023
• Device Catalogue Number: RBY2C0630
• Device Lot Number: F65668
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/12/2017
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/04/2017
• Initial Report FDA Received Date: 05/02/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 69 YR