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

Model Number	RBY2C2860-A
Medical Device Problem Code	Failure to Advance (2524)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	01/12/2018
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.This report is associated with mfr report numbers: 3005168196-2018-00260; 3005168196-2018-00261; 3005168196-2018-00262; 3005168196-2018-00264; 3005168196-2018-00265; 3005168196-2018-00266; 3005168196-2018-00267; 3005168196-2018-00268; 3005168196-2018-00269; 3005168196-2018-00270; 3005168196-2018-00271.
Event or Problem Description
The patient was undergoing a coil embolization procedure in the splenic using ruby coils and a pod packing coil (podj).It was noted that the patient's anatomy was tortuous.During the procedure, the physician successfully implanted six ruby coils in the target vessel using a non-penumbra microcatheter.The physician was then unable to place 11 ruby coils and one podj.It was reported that the physician switched microcatheters three times.The procedure was completed using other coils.There was no report of an averse effect to the patient.
Event or Problem Description
The patient was undergoing a coil embolization procedure in the splenic using ruby coils and a pod packing coil (podj).It was noted that the patient¿s anatomy was tortuous.During the procedure, the physician successfully implanted six ruby coils in the target vessel using a non-penumbra microcatheter.The physician was then unable to advance 11 ruby coils and one podj through the microcatheter and, therefore, all 11 ruby coils and the podj were removed.It was reported that the physician switched microcatheters three times.The procedure was completed using other coils.There was no report of an averse effect to the patient.
Additional Manufacturer Narrative
This report is associated with mfr report numbers: 3005168196-2018-00260, 3005168196-2018-00261, 3005168196-2018-00262, 3005168196-2018-00264, 3005168196-2018-00265, 3005168196-2018-00266, 3005168196-2018-00267, 3005168196-2018-00268, 3005168196-2018-00269, 3005168196-2018-00270, and 3005168196-2018-00271.

• Brand Name: RUBY COIL
• Common Device Name: HCG, KRD
• Manufacturer (Section D): PENUMBRA, INC.; one penumbra place; alameda CA 94502
• MDR Report Key: 7242768
• Report Number: 3005168196-2018-00263
• Device Sequence Number: 19122100
• Product Code: HCG
• UDI-Device Identifier: 00814548013091
• UDI-Public: 00814548013091
• Combination Product (Y/N): Y
• Initial Reporter State: MI
• 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: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 01/12/2018
• Report Date (Section F): 01/01/2005

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: 12/17/2024
• Device Model Number: RBY2C2860-A
• Device Catalogue Number: RBY2C2860
• Device Lot Number: F73238
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Date Report to Manufacturer: 01/10/2005
• Initial Date Received by Manufacturer: 01/12/2018
• Supplement Date Received by Manufacturer: 01/14/2005
• Initial Report FDA Received Date: 02/05/2018
• Supplement Report FDA Received Date: 06/26/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Date Report Sent to FDA: 01/01/2005