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

Catalog Number	RBY2C1857
Medical Device Problem Codes	Failure to Advance (2524); Physical Resistance/Sticking (4012)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	12/17/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Results: the pet lock was broken at the proximal end of the pusher assembly.The pusher assembly had bends and kinks along the length of the device.The embolization coil was not returned for evaluation; therefore, no functional testing could be performed.Conclusions: evaluation of the returned ruby coil revealed a broken pet lock and kinked pusher assembly.Pusher assembly kinks typically occur due to forceful advancement against resistance.The broken pet lock was likely incidental to the reported complaint and contributed to the coil detaching.The embolization coil and lantern identified in the complaint were not returned for evaluation.The root cause of the reported complaint could not be determined.Some of the kinks on the returned pusher assembly were likely also incidental and may have occurred during packaging for return to penumbra.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 varicocele vein using ruby coils.During the procedure, the physician felt resistance while advancing the first ruby coil halfway through the lantern delivery microcatheter (lantern).The physician then re-positioned the lantern and made another attempt to advance the ruby coil, but the same issue occurred.The ruby coil was therefore removed and was not used in the procedure.The lantern was then flushed and the procedure was completed using four 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: 8256743
• Report Number: 3005168196-2019-00115
• Device Sequence Number: 1833017
• Product Code: HCG
• UDI-Device Identifier: 00814548013060
• UDI-Public: 00814548013060
• Combination Product (Y/N): Y
• 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: Physician
• Type of Report: Initial
• Report Date (Section B): 12/18/2018
• Report Date (Section F): 01/01/2005

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: Health Professional
• Device Expiration Date: 07/23/2025
• Device Catalogue Number: RBY2C1857
• Device Lot Number: F78337
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/26/2019
• Was the Report Sent to FDA?: Yes
• Date Report to Manufacturer: 01/10/2005
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/18/2018
• Initial Report FDA Received Date: 01/17/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 21 YR
• Date Report Sent to FDA: 01/01/2005