MAUDE Adverse Event Report: PENUMBRA, INC. LANTERN DELIVERY CATHETER; CATHETER, PERCUTANEOUS

Model Number PXSLIMLAN150STR

Device Problem Unraveled Material (1664)

Patient Problem Foreign Body In Patient (2687)

Event Date 05/03/2023

Event Type  Injury  

Event Description

During deployment of a coil to embolize bleeding, a coil was not fully deployed and was stuck in the micro catheter.Both unraveling coil and micro catheter were removed from patient via sheath but a component of the coil remained in the patient.Vascular surgeon had to go back in 3 times to remove fragments.

• Brand Name: LANTERN DELIVERY CATHETER
• Type of Device: CATHETER, PERCUTANEOUS
• Manufacturer (Section D): PENUMBRA, INC.; one penumbra place; alameda CA 94502
• MDR Report Key: 17019079
• MDR Text Key: 316118155
• Report Number: 17019079
• Device Sequence Number: 1
• Product Code: DQY
• UDI-Device Identifier: 00814548016672
• UDI-Public: (01)00814548016672(17)240328(10)F104932
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 05/17/2023

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: Health Professional
• Device Model Number: PXSLIMLAN150STR
• Device Catalogue Number: PXSLIMLAN150STR
• Device Lot Number: F104932
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 05/17/2023
• Event Location: Hospital
• Date Report to Manufacturer: 05/30/2023
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 05/30/2023
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Other; Required Intervention
• Patient Age: 11315 DA
• Patient Sex: Female
• Patient Weight: 70 KG
• Patient Ethnicity: Hispanic