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

Model Number	RBYPOD5-A
Medical Device Problem Code	Physical Resistance/Sticking (4012)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/20/2021
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 numbers: 3005168196-2021-01123.3005168196-2021-01124.
Event or Problem Description
The patient was undergoing a coil embolization procedure in the splenic artery using pod coils and a non-penumbra microcatheter.During the procedure, the physician encountered resistance while advancing a pod8 coil through the middle of the microcatheter.Therefore, the pod8 was removed from the microcatheter and set side.Next, the physician encountered resistance while advancing a pod5 through the same place in the microcatheter; therefore, the pod5 was removed and set aside.The same issue occurred with a pod6; therefore, the pod6 was also removed and set aside.The physician exchanged the microcatheter for a lantern delivery microcatheter (lantern) and proceeded to re-advance the same pod5 and pod6.It was reported that resistance was encountered while advancing both the pod5 and the pod6; however, the coils were successfully implanted.While advancing the same pod8 through the lantern, the physician encountered resistance.Therefore, the pod8 was removed and was no longer used in the procedure.The procedure was completed using nine pod packing coils (pod pcs) and the same lantern.There was no report of an adverse effect to the patient.

• Brand Name: POD
• Common Device Name: HCG, KRD
• Manufacturer (Section D): PENUMBRA, INC.; one penumbra place; alameda CA 94502
• MDR Report Key: 11865547
• Report Number: 3005168196-2021-01122
• Device Sequence Number: 14329695
• 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: distributor,foreign,health pr
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 04/26/2021
• 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: F96134
• Was Device Available for Evaluation?: No
• 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: 04/26/2021
• Initial Report FDA Received Date: 05/21/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Date Report Sent to FDA: 01/01/2005