MAUDE Adverse Event Report: PENUMBRA, INC. POD5; HCG, KRD

Catalog Number RBYPOD5

Device Problems Detachment Of Device Component (1104); Difficult to Advance (2920)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 11/20/2014

Event Type  malfunction  

Event Description

The patient was undergoing a coil embolization procedure using pod5 and px slim delivery microcatheter.During the procedure, the physician experienced difficulty advancing a pod5 through a px slim and therefore, the pod5 unintentionally detached.The px slim and the detached pod5 were removed from the patient and the procedure continued using new devices.There was no report of an adverse effect on the patient.

Manufacturer Narrative

Conclusion: the product was not returned for evaluation.Without the return of the device, the root cause of the problem cannot be determined; however, the px slim used in the procedure was returned and evaluated.The complaint indicates that resistance was felt while attempting to advance the pod device through the pxslim delivery microcatheter.Evaluation of the returned pxslim delivery microcatheter revealed no issue with the catheter.The catheter was fully functional and within specification.The manufacturing records for this lot were reviewed and did not reveal any outstanding discrepancies, design, or quality concerns.Hospital discarded the device.

• Brand Name: POD5
• Type of Device: HCG, KRD
• Manufacturer (Section D): PENUMBRA, INC.; 1351 harbor bay parkway; alameda CA 94502
• Manufacturer (Section G): PENUMBRA, INC.; 1351 harbor bay parkway; alameda CA 94502
• Manufacturer Contact: kathleen kidd ; 1351 harbor bay parkway; alameda, CA 94502 ; 5107483200
• MDR Report Key: 4346707
• MDR Text Key: 19349877
• Report Number: 3005168196-2014-00877
• Device Sequence Number: 1
• Product Code: HCG
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K141134
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility,Company Representative
• Reporter Occupation: Health Professional
• Type of Report: Initial
• Report Date: 11/20/2014

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: Physician
• Device Expiration Date: 08/31/2022
• Device Catalogue Number: RBYPOD5
• Device Lot Number: F60377
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 11/20/2014
• Initial Date FDA Received: 12/19/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/07/2014
• 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: 52 YR