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

Model Number	RBY2C1035-B
Medical Device Problem Code	Physical Resistance/Sticking (4012)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/08/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Evaluation of the returned pod8 revealed that the pusher assembly mid-joint was retracted through the introducer sheath friction lock.If this occurs, resistance may be experienced during advancement.During functional testing, the pod8 was able to be re-sheathed and then advanced out of its introducer sheath with resistance advancing the coil from its returned position within its introducer sheath.The pod8 was then advanced through a demonstration lantern without an issue.Further evaluation revealed pusher assembly bends.This damage may be incidental to the reported complaint.Evaluation of the returned ruby coil revealed a functional device.The device was returned unsheathed; therefore, during functional testing, the ruby coil was re-sheathed with its introducer sheath without an issue.The ruby coil was then advanced through its introducer sheath and a demonstration lantern without an issue.The root cause of resistance during the procedure could not be determined.Further evaluation revealed pusher assembly bends.This damage may be 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.This report is associated with mfr report number: 3005168196-2021-01485.
Event or Problem Description
The patient was undergoing a coil embolization procedure in the splenic artery using ruby coils, pod coils, and a lantern delivery microcatheter (lantern).It was noted that the patient anatomy was tortuous.During the procedure, while advancing a pod coil, and later a ruby coil, into the target location, the physician lost access with the lantern due to the tortuosity and lack of support with the lantern.The pod coil and ruby coil were removed and re-sheathed.Subsequently, the physician re-accessed the vessel with the lantern and then experienced resistance when advancing the same pod coil and ruby coil through the lantern.Therefore, the pod coil and ruby coil were removed.The procedure was completed using a new pod coil, a new ruby coil, and the same lantern.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: 12131967
• Report Number: 3005168196-2021-01486
• Device Sequence Number: 17246098
• Product Code: HCG
• UDI-Device Identifier: 00814548019062
• UDI-Public: 00814548019062
• Combination Product (Y/N): Y
• Initial Reporter Country: CA
• PMA/510(K) Number: K173614
• 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
• Report Date (Section B): 07/07/2021
• 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: RBY2C1035-B
• Device Catalogue Number: RBY2C1035
• Device Lot Number: F104855
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/11/2021
• Was the Report Sent to FDA?: Yes
• Date Report to Manufacturer: 01/10/2005
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/08/2021
• Initial Report FDA Received Date: 07/07/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 63 YR
• Date Report Sent to FDA: 01/01/2005