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

Model Number	RBY2C1035-A
Health Effect - Clinical Codes	No Consequences Or Impact To Patient (2199); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/12/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The product was not returned for evaluation.Without the return of the device, an investigation cannot be performed.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 in the digestive artery using a ruby coil and a non-penumbra microcatheter.During the procedure, while advancing a ruby coil through the microcatheter the physician experienced resistance.Subsequently, the ruby coil would became stuck and would not advance out of the microcatheter; therefore, the ruby coil was removed.The procedure was completed using a non-penumbra coil and the same microcatheter.There was no report of an adverse effect to the patient.
Additional Manufacturer Narrative
Evaluation of the returned ruby coil revealed kinks on the pusher assembly and offset coil winds near the proximal end of the embolization coil.If the device is forcefully advanced against resistance, damage such as this may occur.During functional testing, resistance was encountered due to the dried blood within the introducer sheath while attempting to advance the ruby coil from its returned position, and the ruby coil could not be advanced at all.Therefore, the functional testing could not be continued.The dried blood inside the introducer sheath was likely incidental to the complaint.The reported resistance experienced during the procedure could not be determined.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.Section h.Box 6.Conclusions code 1: 4316 - the investigation findings do not lead to a clear conclusion about the cause of resistance.H3 other text : placeholder.

• Brand Name: RUBY COIL
• Common Device Name: HCG, KRD
• Manufacturer (Section D): PENUMBRA, INC.; one penumbra place; alameda CA 94502
• MDR Report Key: 11177091
• Report Number: 3005168196-2021-00093
• Device Sequence Number: 2270670
• Product Code: HCG
• UDI-Device Identifier: 00814548013008
• UDI-Public: 00814548013008
• Combination Product (Y/N): Y
• Initial Reporter Country: FR
• PMA/510(K) Number: K120330
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 12/17/2020
• 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: Health Professional
• Device Model Number: RBY2C1035-A
• Device Catalogue Number: RBY2C1035
• Device Lot Number: F92775
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/11/2021
• Was the Report Sent to FDA?: Yes
• Date Report to Manufacturer: 01/10/2005
• Initial Date Received by Manufacturer: 12/17/2020
• Supplement Date Received by Manufacturer: 02/23/2021
• Initial Report FDA Received Date: 01/15/2021
• Supplement Report FDA Received Date: 03/17/2021
• 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