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

Model Number	RBYPOD5-A
Medical Device Problem Codes	Physical Resistance/Sticking (4012); Difficult or Delayed Separation (4044)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/28/2021
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: 3005168196-2021-01909, 3005168196-2021-01911.
Event or Problem Description
The patient was undergoing a coil embolization procedure in the splenic artery using a ruby coil detachment handle (handle), pod coils, a non-penumbra microcatheter, a non-penumbra catheter, and a non-penumbra guide catheter.During the procedure, the physician advanced a pod coil into the target location and attempted to detach it using a handle; however, the pod coil failed to detach after multiple attempts.It was reported that the coil alignment zone separated, but the pod coil did not detach.Therefore, the physician pulled the pusher assembly of the pod coil with the handle to detach it.It was also reported that the physician experienced resistance while inserting the proximal end of the pusher assembly into the handle.Next, the physician advanced another pod coil to the target location and attempted to detach it using the handle; however, the same issue occurred.Therefore, the physician also pulled the pusher assembly of the pod coil with the handle to detach it.The procedure was completed using another handle and eight additional coils.There was no report of an adverse effect to the patient.
Additional Manufacturer Narrative
Please note that the following section was inadvertently missed on the initial mfr report and is being updated on this follow-up # 02 mfr report:3005168196-2021-01910: section d box 6.If implanted, give date.This report is associated with mfr report number: 3005168196-2021-01909; 3005168196-2021-01911.

• Brand Name: POD 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: 12375952
• Report Number: 3005168196-2021-01910
• Device Sequence Number: 4116228
• Product Code: HCG
• UDI-Device Identifier: 00814548019604
• UDI-Public: 00814548019604
• Combination Product (Y/N): Y
• Initial Reporter Country: JA
• PMA/510(K) Number: K173614
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2021
• Reporter Type: Manufacturer
• Report Source: Foreign,Company Representative,Distributor
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 12/27/2021
• 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: RBYPOD5-A
• Device Catalogue Number: RBYPOD5
• Device Lot Number: F96238
• 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: 08/02/2021
• Supplement Date Received by Manufacturer: 01/14/2005
• Initial Report FDA Received Date: 08/27/2021
• Supplement Report FDA Received Date: 12/27/2021
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 02/12/2020
• 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