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

Catalog Number	RBY2C0430
Medical Device Problem Code	Failure to Advance (2524)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	04/04/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Results: the pet lock was intact on the proximal end of the pusher assembly for the ruby coil.The pusher assembly was kinked approximately 1.5, 47.5, 49.5 and 51.0 cm from the proximal end.The embolization coil was stuck inside the returned lantern.Conclusions: evaluation of the returned pod5 confirmed that the pusher assembly was kinked.This type of damage was likely a result of mishandling during retraction as reported in the complaint.Further evaluation of the returned device revealed that the embolization coil had offset coil winds.This damage was likely incidental to the reported issue and likely occurred due to packaging the device for returned to penumbra without the embolization coil being protected.Evaluation of the returned podj revealed that the distal tip of the introducer sheath had coagulated blood inside.While attempting to advance the podj within its introducer sheath, resistance was encountered and the device could not be advanced out of its sheath or through a demonstration microcatheter for the reported issue.The root cause of the reported issue could not be determined.Evaluation of the returned ruby coil revealed it was kinked along its length and stuck inside the lantern.These damages were likely incidental to the reported failure and occurred post-procedure.The ruby coil¿s reported inability to advance out of the returned lantern was likely due to the lantern¿s distal ovalization.Evaluation of the lantern revealed an ovalization on its distal tip.This damage may have been due to forcefully manipulating the device within patient anatomy or during preparation for the procedure.This ovalization likely contributed to the ruby coil¿s inability to advance out the lantern¿s distal tip.Further evaluation revealed the ruby coil was stuck inside the returned lantern.This is likely incidental and occurred as a result of the devices being removed from the patient together and packaged for return to penumbra.Evaluation of the returned ruby coil revealed no visible damage.It was reported that the device was removed due to a sizing issue.Evaluation of the returned ruby coil pusher assemblies revealed that the pet locks were broken and the embolization coils were detached.There was no reported functional issue for the returned devices.It was reported that the pusher assemblies belongs to two successful detached devices.Further evaluation of the revealed that the pusher assembly was fractured.This damage was likely incidental and may have occurred while packaging the devices for return.Penumbra coils and catheters are visually 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: 3005168196-2018-00921, 3005168196-2018-00922, 3005168196-2018-00924.
Event or Problem Description
The patient was undergoing a coil embolization procedure to treat a pulmonary arteriovenous malformation (avm) using a pod5, a pod packing coil (podj), ruby coils and a lantern delivery microcatheter (lantern).During the procedure, while attempting to deploy a pod5 into the target vessel using the lantern, the physician determined that the pod5 was oversized and decided to retract it; however, during the retraction, the pod5 became kinked.The physician then opened a podj and attempted to advance it through the lantern; however, the podj kicked the lantern out of the aneurysm and therefore, the podj was removed.The physician then smoothly advanced a ruby coil within the lantern until the last one centimeter from the distal tip of the lantern and the physician thought that there may be a kink in the lantern; therefore, the lantern and ruby coil were removed.Upon removal, the lantern was confirmed to be kinked.The procedure was completed using other coils, the same diagnostic catheter, a new lantern and additional ruby coils.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: 7485442
• Report Number: 3005168196-2018-00923
• Device Sequence Number: 1592631
• Product Code: HCG
• UDI-Device Identifier: 00814548012872
• UDI-Public: 00814548012872
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• 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
• Report Date (Section B): 04/04/2018

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: 11/26/2025
• Device Catalogue Number: RBY2C0430
• Device Lot Number: F80747
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/13/2018
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/04/2018
• Initial Report FDA Received Date: 05/03/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 25 YR