MAUDE Adverse Event Report: PENUMBRA, INC. POD4; HCG, KRD

Catalog Number RBYPOD4

Device Problems Kinked (1339); Physical Resistance (2578)

Patient Problems No Consequences Or Impact To Patient (2199); No Known Impact Or Consequence To Patient (2692)

Event Date 03/14/2018

Event Type  Injury  

Manufacturer Narrative

The product was disposed of by the hospital and is no longer available for return.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.

Event Description

The patient was undergoing a coil embolization procedure in the distal anterior cerebral artery (aca) using pod4s.During the procedure, the physician felt resistance while attempting to advance the proximal end of a pod4 into the target vessel through a px slim delivery microcatheter (px slim).The physician, therefore, attempted to reposition the px slim and retracted the pod4 to decrease the tension and consequently, the pod4 unintentionally detached.The physician removed the pod4 using a snare device.The procedure was then completed using a new smaller microcatheter and additional coils.There was no report of an adverse effect to the patient.

Manufacturer Narrative

As this complaint was submitted to the fda by the user facility with the following reference number: mw5077102.

Event Description

Additional information received on 24-may-2018 stated that "impact on patient outcome still unclear, as he has such a poor neurological exam from his initial aneurysm bleed that detecting a new stroke is difficult.".

• Brand Name: POD4
• 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: 7425171
• MDR Text Key: 105278081
• Report Number: 3005168196-2018-00765
• Device Sequence Number: 1
• Product Code: HCG
• UDI-Device Identifier: 00814548013756
• UDI-Public: 00814548013756
• 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: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 01/01/2005,03/14/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Physician
• Device Catalogue Number: RBYPOD4
• Device Lot Number: F75631
• 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: 03/14/2018
• Initial Date FDA Received: 04/12/2018
• Supplement Dates Manufacturer Received: 01/14/2005
• Supplement Dates FDA Received: 10/11/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/14/2017
• 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 Outcome(s): Required Intervention
• Patient Age: 42 YR