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

Model Number	RBY4C0835-B
Medical Device Problem Codes	Failure to Advance (2524); Physical Resistance/Sticking (4012); Premature Separation (4045)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/29/2021
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.This report is associated with mfr report number: 3005168196-2021-02378.
Event or Problem Description
The patient was undergoing a coil embolization procedure in the subclavian artery using ruby coils, pod coils, a lantern delivery microcatheter (lantern), 6f sheath, and a non-penumbra catheter.It was noted that the patient¿s anatomy was mildly tortuous.During the procedure, the physician experienced resistance advancing a ruby coil from the distal tip of the lantern to the target location.Subsequently, the ruby coil became stuck, and the physician decided to retract the ruby coil.However, while retracting, the ruby coil unintentionally detached inside the lantern.Therefore, the lantern containing the detached ruby coil was removed and the coil was flushed out.It was also reported that the lantern was flushed on the back table.The physician then reinserted the same lantern and while advancing a pod coil through the middle of the lantern, the physician experienced resistance and, the pod coil became stuck.Therefore, the pod coil was removed.The procedure was completed using pod packing coils (pod pc), other coils, and the same lantern.There was no report of an adverse effect to the patient.
Additional Manufacturer Narrative
Please note, that the device associated with this complaint was expected to be returned.However, the device has not been received by the manufacturer.Therefore, 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.This report is associated with mfr report number: 1.3005168196-2021-02378.H3 other text: placeholder.

• Brand Name: RUBY COIL
• Common Device Name: HCG, KRD
• Manufacturer (Section D): PENUMBRA, INC.; one penumbra place; alameda CA 94502
• Manufacturer Contact: veronica farris ; one penumbra place; alameda, CA 94502 ; 5107483200
• MDR Report Key: 12694323
• Report Number: 3005168196-2021-02377
• Device Sequence Number: 14698901
• Product Code: HCG
• UDI-Device Identifier: 00814548018386
• UDI-Public: 00814548018386
• Combination Product (Y/N): Y
• Initial Reporter Country: JA
• PMA/510(K) Number: K173614
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Distributor
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 12/14/2021
• 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: RBY4C0835-B
• Device Catalogue Number: RBY4C0835
• Device Lot Number: F95436
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• 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: 10/01/2021
• Supplement Date Received by Manufacturer: 01/14/2005
• Initial Report FDA Received Date: 10/25/2021
• Supplement Report FDA Received Date: 12/14/2021
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 01/08/2020
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown
• Date Report Sent to FDA: 01/01/2005