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

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Abscess (1690)

Event Date 02/01/2011

Event Type  Injury  

Manufacturer Narrative

The product was not returned for evaluation.From the information provided, there is no indication that there was any device malfunction, nonconformance, or misuse that contributed to the reported event.Potential adverse events in the pod system instructions for use (ifu) include, but are not limited to, hematoma or hemorrhage at access site of entry, infection, intracranial hemorrhage, ischemia, including death.The product lot number was not provided, therefore, the manufacturing records could not be reviewed.

Event Description

During its post-market surveillance activities on 17-mar-2022, penumbra inc.Became aware of a journal article titled, "proximal embolization of splenic artery inacute trauma: comparison between penumbra occlusion device versus coils or amplatzer vascular plug" (jambon et al.2018).This article retrospectively reviewed patients treated at a single center for splenic trauma between february 2011 and october 2016, including twelve patients treated using pod coils.No procedural complications were reported.Two patients developed a regressive abscess during hospitalization after use of pod coils to treat splenic artery trauma.Subsequently, each patient was treated with antibiotics.In both cases, the relationship between the event and the pod coils was not specified.It was not possible to ascertain specific device information from the article, or to match the events reported with previously reported complaints.Therefore, this report addresses all malfunctions and/or adverse events within this literature source.

• Brand Name: POD
• 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: 14104601
• MDR Text Key: 289215750
• Report Number: 3005168196-2022-00169
• Device Sequence Number: 1
• Product Code: HCG
• Combination Product (y/n): N
• Reporter Country Code: FR
• PMA/PMN Number: K173614
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Literature,Health Professional
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 01/01/2005,04/13/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/13/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• 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: 03/17/2022
• 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 Outcome(s): Required Intervention