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

Model Number	RBY4C0860-A
Medical Device Problem Codes	Failure to Advance (2524); Physical Resistance/Sticking (4012)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/08/2020
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.
Event or Problem Description
The patient was undergoing a coil embolization procedure in the ovarian vein using a ruby coil and a non-penumbra microcatheter.During the procedure, while advancing a ruby coil through the microcatheter, the ruby coil became stuck in 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
Please note that the device in complaint was not expected to be returned; however, on 14-may-2021 the device was received.Based on this information, corrections were made to: 1.Section d.Box 10: device available for evaluation? (do not send to fda) 2.Section h.Box 3: device returned to manufacturer? 3.Section h.Box 3: device evaluated by manufacturer? 4.Section h.Box 6: method code 1, method code 2, and method code 3 5.Section h.Box 6: results code 1 6.Section h.Box 6.Conclusions code 1 additional information was added to: 1.Section d.Box 10: returned to manufacturer on (mm/dd/yyyy) please note that the following section was incorrectly reported on the initial mfr report and is being corrected on this follow up #01 mfr report:3005168196-2021-00638 1.Section g.Box 5.510(k) evaluation of the returned ruby coil revealed offset coil winds.If the device is forcefully advanced against resistance, damage such as this may occur.During functional testing, the remainder of the embolization coil was able to be advanced out of the introducer sheath with resistance.The ruby coil was re-sheathed back into its introducer sheath with resistance.Then resistance was experienced due to the offset coil winds, and the ruby coil could not advance out of tis introducer sheath.The root cause of resistance during the procedure could not be determined.Further evaluation revealed pusher assembly bends.This damage was likely incidental to the reported complaint.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.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: 11589948
• Report Number: 3005168196-2021-00638
• Device Sequence Number: 11957423
• Product Code: HCG
• UDI-Device Identifier: 00814548013213
• UDI-Public: 00814548013213
• 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): 07/13/2021
• 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: RBY4C0860-A
• Device Catalogue Number: RBY4C0860
• Device Lot Number: F94408
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/14/2021
• Was the Report Sent to FDA?: Yes
• Date Report to Manufacturer: 01/10/2005
• Initial Date Received by Manufacturer: 03/02/2021
• Supplement Date Received by Manufacturer: 06/07/2021
• Initial Report FDA Received Date: 03/30/2021
• Supplement Report FDA Received Date: 07/13/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 52 YR
• Date Report Sent to FDA: 01/01/2005