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

Model Number RBY4C1035-B

Device Problem Component Missing (2306)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 06/29/2021

Event Type  malfunction  

Manufacturer Narrative

This device is available for return.A follow up mdr will be submitted upon completion of the device investigation.

Event Description

The patient was undergoing a coil embolization procedure in the left subclavian artery using ruby coils and a lantern delivery microcatheter (lantern).During the procedure, while attempting to advance the ruby coil into the lantern, the physician noticed the ruby coil was not within the introducer sheath when advancing the pusher assembly.It was reported that the introducer sheath was retracted to visualize the ruby coil; however, the coil was not inside the introducer sheath.Therefore, it was removed.It was reported that the ruby coil was not in the packaging hoop or product box.The procedure was completed using a new ruby coil.There was no report of an adverse effect to the patient.

Manufacturer Narrative

Evaluation of the returned ruby coil confirmed that the embolization coil was detached from the pusher assembly.Further evaluation revealed a pusher assembly kink and bends throughout its length, the pull wire was within its original position inside the ddt, and the introducer sheath was ovalized.This damage was incidental to the reported complaint.The root cause of the embolization coil not being intact with the pusher assembly could not be determined.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.Section h.Box 6.Results code 2: 4247 - the embolization coil was detached from the pusher assembly, and was not returned for evaluation.Section h.Box 6.Conclusions code 1: 4316 - the investigation findings do not lead to a clear conclusion about the root cause of the reported event h3 other text : placeholder.

• Brand Name: RUBY COIL
• Type of Device: HCG, KRD
• Manufacturer (Section D): PENUMBRA, INC.; one penumbra place; alameda CA 94502
• MDR Report Key: 12196756
• MDR Text Key: 262465787
• Report Number: 3005168196-2021-01607
• Device Sequence Number: 1
• Product Code: HCG
• UDI-Device Identifier: 00814548018669
• UDI-Public: 00814548018669
• Combination Product (y/n): Y
• PMA/PMN Number: K173614
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup
• Report Date: 01/01/2005,07/20/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/20/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: RBY4C1035-B
• Device Catalogue Number: RBY4C1035
• Device Lot Number: F87023
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/20/2021
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 01/01/2005
• Date Report to Manufacturer: 01/10/2005
• Date Manufacturer Received: 01/14/2005
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 66 YR