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

Model Number	RBY2C0530-A
Medical Device Problem Code	Failure to Advance (2524)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	02/16/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
This device is available for return.A follow up mdr will be submitted upon completion of the device investigation.
Event or Problem Description
The patient was undergoing a coil embolization procedure in the splenic artery using a ruby coil.During the procedure, the ruby coil would not advance within its introducer sheath; therefore, it was removed.The procedure was completed using additional ruby coils.There was no report of an adverse effect to the patient.
Additional Manufacturer Narrative
Results: the pet lock was intact on the proximal end of the pusher assembly.The embolization coil was intact with its pusher assembly and had offset coil winds throughout its length.Coagulated blood inside was present on the embolization coil within the introducer sheath.Conclusions: evaluation of the returned ruby coil revealed that the embolization coil had offset coil winds inside the introducer sheath.If the ruby coil is forcefully manipulated against resistance, damage such as offset coil winds may occur.During the functional test, resistance was encountered while advancing the ruby coil out of its introducer sheath.However, the ruby coil was able to be advance out of its sheath.After re-sheathing the ruby coil, resistance was encountered while attempting to advance the ruby coil through a demonstration microcatheter, and the ruby coil could not be advanced any further.The offset coil winds may have contributed to the resistance encountered during procedure and the functional test.No other devices associated with the complaint were returned for evaluation, and therefore, the root cause of the initial resistance could not be determined.Further evaluation revealed coagulated blood within the introducer sheath.This damage was likely incidental to the reported complaint but may have contributed to the resistance during the functional test.Penumbra coils are visually 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.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: 9826564
• Report Number: 3005168196-2020-00347
• Device Sequence Number: 13794885
• Product Code: HCG
• UDI-Device Identifier: 00814548012919
• UDI-Public: 00814548012919
• Combination Product (Y/N): Y
• Initial Reporter Country: AS
• 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): 02/17/2020
• 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 Expiration Date: 05/17/2025
• Device Model Number: RBY2C0530-A
• Device Catalogue Number: RBY2C0530
• Device Lot Number: F77215
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/26/2020
• Was the Report Sent to FDA?: Yes
• Date Report to Manufacturer: 01/10/2005
• Initial Date Received by Manufacturer: 02/17/2020
• Supplement Date Received by Manufacturer: 05/08/2020
• Initial Report FDA Received Date: 03/12/2020
• Supplement Report FDA Received Date: 05/14/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 37 YR
• Date Report Sent to FDA: 01/01/2005