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

Catalog Number	RBY2C0930
Medical Device Problem Codes	Physical Resistance (2578); Difficult to Advance (2920)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	12/18/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Results: the pusher assembly of the ruby coil was kinked in multiple locations throughout its length.The pusher assembly midjoint was retracted proximal to the introducer sheath friction lock.The embolization coil was intact with the pusher assembly.Conclusions: evaluation of the returned device revealed the pusher assembly midjoint was retracted proximal to the introducer sheath friction lock.The introducer sheath friction lock inner diameter (id) is smaller than the rest of the introducer sheath, which allows the introducer sheath to properly seat on the ruby coil mid-joint.If the pusher assembly midjoint is forcefully withdrawn beyond the introducer sheath friction lock, it is likely that resistance will be experienced by the physician upon attempting to advance the ruby coil.Since the ruby coil was reportedly able to advance through the introducer sheath and into the lantern delivery microcatheter (lantern) the retraction of the midjoint proximal to the friction lock was likely incidental and likely occurred after removal of the ruby coil from the procedure.Since the ruby coil could not be advanced through its introducer sheath during functional testing, it could not be tested for advancement through a microcatheter, and the root cause of the reported resistance could not be determined.The kinks observed throughout the pusher assembly were likely incidental and may have occurred during packaging for return to penumbra.The lantern mentioned in the complaint was not returned for evaluation.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.
Event or Problem Description
The patient was undergoing a coil embolization procedure in the hypogastric artery using ruby coils.During the procedure, while attempting to place a ruby coil into the aneurysm, the lantern delivery microcatheter (lantern) came out of the target vessel due to its positioning; therefore, the ruby coil was removed and the lantern repositioned.While attempting to re-advance the ruby coil through the lantern, the physician experienced resistance after advancing approximately one third of the coil into the lantern; therefore, it was removed.The procedure was completed using additional ruby 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: 7197777
• Report Number: 3005168196-2018-00131
• Device Sequence Number: 1863613
• Product Code: HCG
• UDI-Device Identifier: 00814548012995
• UDI-Public: 00814548012995
• Combination Product (Y/N): N
• Initial Reporter State: NC
• 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): 12/18/2017

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: 08/08/2025
• Device Catalogue Number: RBY2C0930
• Device Lot Number: F78606
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/04/2018
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/18/2017
• Initial Report FDA Received Date: 01/16/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 73 YR