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

Catalog Number	RBY4C0406
Medical Device Problem Code	Detachment Of Device Component (1104)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	04/02/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Results: the ruby coil was kinked throughout its length and wrapped up.The pet lock was intact on the proximal end of the pusher assembly.The embolization coil was detached from the pusher assembly and the stretch resistant wire (sr wire) was fractured.Conclusions: evaluation of the returned devices revealed that the embolization coil was detached from the pusher assembly and the stretch resistant (sr) wire was fractured.Fracture of the sr wire typically occurs due to forceful manipulation of the ruby coil against resistance and will allow the embolization coil to detach.Further evaluation revealed that the distal tip of the lantern was kinked.This damage may have occurred due to forceful manipulation of the lantern within tortuous anatomy and may have contributed to the unintentional detachment of the ruby coil.Further evaluation revealed that the ruby coil pusher assembly and lantern were kinked throughout their lengths.This damage was likely incidental and likely occurred during packaging for return to penumbra.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.This report is associated with mfr report number: 3005168196-2017-00695.
Event or Problem Description
The patient was undergoing a coil embolization procedure to treat a gastrointestinal (gi) bleed using ruby coils.It was noted that the patient had very tortuous anatomy.During the procedure, the physician deployed and detached initial coils into the target vessel using a lantern delivery microcatheter (lantern).While attempting to advance a new ruby coil through the lantern, the physician did not mention any resistance; however, the ruby coil unintentionally detached in the lantern.Therefore, the physician removed the lantern containing the detached coil from the patient.The procedure was then completed using another manufacturer¿s microcatheter and gel foam.There was no alleged deficiency against the lantern.The physician wanted to use a smaller microcatheter to finish the procedure.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: 6546020
• Report Number: 3005168196-2017-00694
• Device Sequence Number: 16176455
• Product Code: HCG
• UDI-Device Identifier: 00814548013169
• UDI-Public: 00814548013169
• Combination Product (Y/N): N
• Initial Reporter State: CA
• 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): 04/06/2017

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: 12/05/2024
• Device Catalogue Number: RBY4C0406
• Device Lot Number: F73034
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/14/2017
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/06/2017
• Initial Report FDA Received Date: 05/04/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 69 YR