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

Catalog Number	RBY4C0630
Medical Device Problem Codes	Detachment Of Device Component (1104); Failure to Advance (2524); Physical Resistance (2578)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	02/26/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Results: the pet lock was intact on the proximal end of the pusher assembly.The pusher assembly was fractured approximately 46.0 cm from the proximal end and kinked approximately 47.0 cm from the proximal end.The embolization coil was detached from the pusher assembly and had offset coil winds throughout its length.Conclusions: evaluation of the returned device revealed the pusher assembly was kinked and fractured, and the embolization coil had offset winds throughout its length.This damage likely occurred due to forceful advancement of the ruby coil against resistance.Fracture of the pusher assembly may allow the pull wire to retract out of the distal detachment tip (ddt), which would allow the embolization coil to detach.The root cause of the initial resistance could not be determined.The non-penumbra microcatheter 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.
Event or Problem Description
The patient was undergoing a coil embolization procedure in the gastroduodenal artery (gda) using ruby coils.During the procedure, while advancing an initial ruby coil through a non-penumbra microcatheter, the physician felt resistance and the ruby coil became stuck.The physician attempted to retract the ruby coil, however the embolization coil then unintentionally detached from the pusher assembly.The physician therefore removed the microcatheter with the ruby coil inside, and the procedure was completed using a lantern delivery microcatheter (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: 7373199
• Report Number: 3005168196-2018-00634
• Device Sequence Number: 2023541
• Product Code: HCG
• UDI-Device Identifier: 00814548013190
• UDI-Public: 00814548013190
• 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: Physician
• Type of Report: Initial
• Report Date (Section B): 02/27/2018

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: 10/22/2024
• Device Catalogue Number: RBY4C0630
• Device Lot Number: F72454
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/06/2018
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/27/2018
• Initial Report FDA Received Date: 03/27/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 64 YR