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

Catalog Number	RBY2C0305
Medical Device Problem Codes	Stretched (1601); Device Operates Differently Than Expected (2913)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	01/06/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The product was not returned for evaluation.Without the return of the device, the root cause of the problem cannot be determined.The manufacturing records for this lot were reviewed and did not reveal any outstanding discrepancies, design, or quality concerns.The hospital disposed of the device.
Event or Problem Description
The patient was undergoing a coil embolization procedure in the renal artery using ruby coils.During the procedure, the physician placed a ruby coil in the aneurysm; however, the physician was not satisfied with the way the ruby coil was filling the aneurysm; therefore, it was removed.The hospital staff was unable to re-sheath the ruby coil into the introducer sheath and noticed that the ruby coil looked slightly stretched.The procedure was completed using the same non-penumbra microcatheter and new ruby coils.It should be noted that the physician reported maintaining continuous flush and using a rotating hemostasis valve.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: 6306088
• Report Number: 3005168196-2017-00155
• Device Sequence Number: 16222450
• Product Code: HCG
• UDI-Device Identifier: 00814548012810
• UDI-Public: 00814548012810
• Combination Product (Y/N): N
• Initial Reporter State: CO
• 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): 01/09/2017

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: 06/23/2023
• Device Catalogue Number: RBY2C0305
• Device Lot Number: F64575
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/09/2017
• Initial Report FDA Received Date: 02/06/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 19 YR