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

Catalog Number RBYPODJ45

Device Problem Device Handling Problem (3265)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 10/17/2018

Event Type  malfunction  

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: 3005168196-2018-02252.

Event Description

The patient was undergoing a coil embolization procedure in the renal artery using pod10 coils (pod10) and pod packing coils (podj).It was noted that the patient¿s anatomy was tortuous.During the procedure, the physician advanced a pod10 into the target vessel using a lantern delivery microcatheter (lantern); however, despite numerous attempts, the pod10 would not form.It was also reported that despite the vessel being sized at 10mm, the pod10 still would not form.The physician then removed the coil and re-sheath it.Later in the case, the physician attempted to advance the same pod10 through the lantern into a different location in the renal artery, however, experienced extreme stiffness and resistance.It was also noted that the physician was forcing the pod10 into the lantern.The pod10 was then removed from the patient.The physician then implanted two podj¿s into the target vessel with no issues.While the tech was handing a new podj to the physician, he accidentally dropped it.The coil was thus contaminated and not used in the procedure.The procedure was completed using the same lantern and additional pod¿s and podj¿s.There was no report of an adverse effect to the patient.

• Brand Name: POD J
• Type of Device: HCG, KRD
• Manufacturer (Section D): PENUMBRA, INC.; one penumbra place; alameda CA 94502
• Manufacturer Contact: veronica farris ; one penumbra place; alameda, CA 94502 ; 510748-320
• MDR Report Key: 8081672
• MDR Text Key: 128081214
• Report Number: 3005168196-2018-02253
• Device Sequence Number: 1
• Product Code: HCG
• UDI-Device Identifier: 00814548017662
• UDI-Public: 00814548017662
• Combination Product (y/n): Y
• Reporter Country Code: US
• PMA/PMN Number: K170852
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 01/01/2005,10/17/2018

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
• Device Operator: Health Professional
• Device Catalogue Number: RBYPODJ45
• Device Lot Number: F79449
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 01/01/2005
• Date Report to Manufacturer: 01/10/2005
• Initial Date Manufacturer Received: 10/17/2018
• Initial Date FDA Received: 11/16/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/08/2017
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Age: 73