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

Catalog Number	RBY2C0320
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	08/04/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Results: the pet lock was intact on the proximal end of the first returned ruby coil¿s pusher assembly.The pusher assembly was kinked approximately 100.0 cm from the proximal end.The embolization coil was detached from the pusher assembly and the stretch resistant wire (sr wire) was fractured.Conclusions: evaluation of the returned ruby coil revealed the sr wire was fractured, the embolization coil was detached, and the pusher assembly was kinked.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.The pusher assembly kink likely occurred due to forceful advancement against resistance.The root cause of the initial reported resistance could not be determined.Evaluation of the returned podj revealed it was kinked in two locations.This damage was likely incidental and may have occurred during packaging for return to penumbra.The podj was advanced through a demonstration microcatheter with only minor resistance experienced while advancing the kinked regions into the microcatheter.The second ruby coil and the non-penumbra microcatheter mentioned in the complaint were 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.This report is associated with mfr report number: 3005168196-2017-01468.
Event or Problem Description
The patient was undergoing a coil embolization procedure in the gastroduodenal artery (gda) using ruby coils.During the procedure, the physician felt resistance and was unable to advance a ruby coil through a non-penumbra microcatheter; therefore, the ruby coil was retracted.Upon retraction, the physician still felt resistance and the ruby coil unintentionally detached within the microcatheter.The physician therefore removed the microcatheter with the ruby coil inside, and then flushed to remove the ruby coil.The same microcatheter was reinserted, and then this occurred again with a second ruby coil, before a third ruby coil was successfully placed.A pod5 was successfully placed, and then the physician felt resistance and was unable to advance a pod packing coil (podj) through the microcatheter.The podj was therefore removed, and the procedure was completed using a shorter podj and the same microcatheter.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: 6839024
• Report Number: 3005168196-2017-01467
• Device Sequence Number: 13469782
• Product Code: HCG
• UDI-Device Identifier: 00814548012834
• UDI-Public: 00814548012834
• Combination Product (Y/N): N
• Initial Reporter State: MA
• 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): 08/04/2017

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: 01/18/2025
• Device Catalogue Number: RBY2C0320
• Device Lot Number: F73880
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/16/2017
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/04/2017
• Initial Report FDA Received Date: 09/01/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 46 YR