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

Catalog Number	RBY2C1460
Medical Device Problem Code	Migration (4003)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/31/2023
Type of Reportable Event	Malfunction
Event or Problem Description
The patient was undergoing a coil embolization procedure in the subclavian artery using pod packing coils (pod pc), ruby coils, and a lantern delivery microcatheter (lantern).During the procedure, the physician placed three pod pcs in target vessel using the lantern.It was reported that after placing the three pod pcs, the physician noticed the distal end and midshaft of the lantern was kinked by the coil compaction.Therefore, the lantern was removed.The physician then inserted a new lantern in the target location and advanced additional pod pcs and ruby coils into the vessel.Subsequently, the physician pulled back on the lantern to be removed and noticed all of the previously placed pod pcs and ruby coils that were implanted had migrated from the subclavian artery to the brachial artery under fluoroscopy.The lantern was removed, and the physician performed a cutdown surgery and removed the migrated pod pcs and ruby coils.The procedure had ended at this point.There was no report of an adverse effect to the patient.
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.This report is associated with mfr report numbers: 3005168196-2023-00186, 3005168196-2023-00187, 3005168196-2023-00188,3005168196-2023-00190,3005168196-2023-00191, 3005168196-2023-00192, 3005168196-2023-00193, 3005168196-2023-00194.

• 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: 16797153
• Report Number: 3005168196-2023-00189
• Device Sequence Number: 3252621
• Product Code: HCG
• UDI-Device Identifier: 00814548019116
• UDI-Public: 814548019116
• Combination Product (Y/N): N
• Initial Reporter State: OK
• Initial Reporter Country: US
• PMA/510(K) Number: K170852
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 04/24/2023
• 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 Catalogue Number: RBY2C1460
• Device Lot Number: F89455
• 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: 03/31/2023
• Initial Report FDA Received Date: 04/24/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 04/19/2019
• 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: Male
• Date Report Sent to FDA: 01/01/2005