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

Catalog Number	RBY2C1857
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	11/30/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Results: the pet lock was intact on the proximal end of the ruby coil pusher assembly.The pusher assembly was kinked in multiple locations throughout its length.The embolization coil was intact with the pusher assembly within the introducer sheath, and was compressed and offset on the proximal end.Dried blood was observed throughout the introducer sheath and embolization coil.During functional analysis, the ruby coil could not be advanced through its introducer sheath due to the compressed and offset coil winds.Conclusions: evaluation of the returned device revealed the embolization coil was intact with the pusher assembly.Therefore, the reported unintentional detachment could not be confirmed.Further evaluation revealed the embolization coil was compressed.This damage may have occurred due to forceful advancement of the ruby coil against resistance.The root cause of the initial resistance experienced during advancement could not be determined.The kinks observed throughout the pusher assembly were likely incidental and may have occurred during packaging for return to penumbra.Dried blood was observed throughout the introducer sheath and embolization coil.If a rotating hemostasis valve (rhv) and continuous flush are not used, blood may be more likely to dry throughout the introducer sheath and embolization coil.The non-penumbra microcatheter 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 to treat a type ii endoleak using ruby coils.During the procedure, while attempting to advance a ruby coil through a non-penumbra microcatheter, the physician experienced resistance and retracted the coil.While attempting to re-advance the ruby coil, resistance was encountered again and upon retraction, the ruby coil unintentionally detached within the microcatheter.Therefore, the ruby coil pusher assembly was removed and the detached coil was aspirated out of the microcatheter.The procedure was completed using seven additional ruby coils, the same microcatheter and a 3cc flush syringe with no issues.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: 7155236
• Report Number: 3005168196-2017-02307
• Device Sequence Number: 1274750
• Product Code: HCG
• UDI-Device Identifier: 00814548013060
• UDI-Public: 00814548013060
• Combination Product (Y/N): N
• Initial Reporter State: ID
• 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): 12/01/2017

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: 01/04/2025
• Device Catalogue Number: RBY2C1857
• Device Lot Number: F73544
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/19/2017
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/01/2017
• Initial Report FDA Received Date: 12/29/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 67 YR