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

Catalog Number RBYPOD5

Device Problems Defective Device (2588); Physical Resistance/Sticking (4012)

Patient Problem Urinary Retention (2119)

Event Date 08/31/2018

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 product lot number was not provided, therefore, the manufacturing records could not be reviewed.

Event Description

The patient was undergoing a coil embolization procedure using pod5s.During the procedure, the physician felt resistance while advancing a pod5 within a lantern delivery microcatheter (lantern) and, therefore, the pod5 was removed.It was noted that there was damage to the pod5.The procedure was completed using ruby coils and the same lantern.There was no report of an adverse effect to the patient.

• Brand Name: POD5
• 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 ; 5107483200
• MDR Report Key: 7924208
• MDR Text Key: 122459118
• Report Number: 3005168196-2018-01941
• Device Sequence Number: 1
• Product Code: HCG
• UDI-Device Identifier: 00814548013787
• UDI-Public: 00814548013787
• Combination Product (y/n): Y
• Reporter Country Code: US
• PMA/PMN Number: K141134
• 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: 01/01/2005,09/04/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/01/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: RBYPOD5
• 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
• Date Manufacturer Received: 09/04/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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: 81 YR