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

Catalog Number	RBY4C0406
Medical Device Problem Code	Difficult or Delayed Separation (4044)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/22/2022
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.This report is associated with mfr report number: 3005168196-2022-00340.
Event or Problem Description
The patient was undergoing a coil embolization procedure to treat an inferior mesenteric artery (ima) endoleak using ruby coils, a pod packing coil (pod pc), a non-penumbra microcatheter, and guidewire (glidewire).During the procedure, the physician advanced a ruby coil to the target vessel and attempted to detach it manually by breaking the pusher assembly; however, the ruby coil failed to detach.Therefore, the ruby coil was removed.Next, the physician advanced two ruby coils to the target vessel and attempted to detach the coils using the handle; however, it was unsuccessful.The physician then manually detached the two ruby coils by breaking the pusher assemblies of the coils.It was reported that the ruby coils detached partially in the microcatheter; therefore, the physician pushed the coils out of the microcatheter and into the target location using the guidewire.It was also reported that the physician experienced resistance while advancing the guidewire to push the detached ruby coils into the target location.Then, the physician advanced the pod pc to the target vessel and attempted to detach it using the handle; however, it was also unsuccessful.Subsequently, the physician attempted to manually detach the pod pc; however, the pod pc still failed to detach.Therefore, the pod pc was removed.The procedure was completed using non-penumbra coils (pushable coils) and the same microcatheter.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
• Manufacturer Contact: veronica farris ; one penumbra place; alameda, CA 94502 ; 5107483200
• MDR Report Key: 15047960
• Report Number: 3005168196-2022-00341
• Device Sequence Number: 14619572
• Product Code: HCG
• UDI-Device Identifier: 00814548018331
• UDI-Public: 814548018331
• Combination Product (Y/N): N
• Initial Reporter State: MN
• Initial Reporter Country: US
• PMA/510(K) Number: K173614
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2022
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 07/18/2022
• 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: RBY4C0406
• Device Lot Number: F113619
• 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: 06/22/2022
• Initial Report FDA Received Date: 07/18/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 03/15/2022
• 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