MAUDE Adverse Event Report: PENUMBRA, INC. LANTERN DELIVERY MICROCATHETER; DQY

Model Number PXSLIMLAN135T45

Device Problems Break (1069); Appropriate Term/Code Not Available (3191)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 12/15/2019

Event Type  malfunction  

Manufacturer Narrative

The device has been returned and the investigation results are pending.A follow up mdr will be submitted upon completion of the device investigation.No appropriate term or code available to describe the issue of lantern not responding well.

Event Description

The patient was undergoing a coil embolization procedure in the left gastric artery using a lantern delivery microcatheter (lantern) and other catheters.It was reported that the patient¿s anatomy was extremely tortuous.During the procedure, the physician successfully placed multiple penumbra coils in various vessels around the left gastric artery and short gastric arteries using the lantern and different catheters.It was noted that due to the patient's tortuous anatomy, multiple catheters and wires were exchanged.While advancing and retracting the lantern through a catheter in the vessel, the physician felt the lantern was not responding well.Upon removal, the physician noticed that the radiopaque band of the lantern had a tear.The procedure was completed using another lantern and another catheter.There was no report of an adverse effect to the patient.

Manufacturer Narrative

Results: the returned lantern was ovalized at approximately 132.0 cm from the hub and the catheter lumen was punctured at the same location.Conclusions: evaluation of the returned lantern confirmed a catheter lumen puncture and revealed a distal ovalization.These damages may have occurred due to forceful manipulation of the lantern inside the reported extremely tortuous patient¿s anatomy.No other devices associated with the complaint were returned for evaluation.Penumbra catheters are inspected during in-process inspection and during quality inspection after manufacturing.The product lot number was not provided, therefore, the manufacturing records could not be reviewed.

• Brand Name: LANTERN DELIVERY MICROCATHETER
• Type of Device: DQY
• Manufacturer (Section D): PENUMBRA, INC.; one penumbra place; alameda CA 94502
• MDR Report Key: 9560496
• MDR Text Key: 176992747
• Report Number: 3005168196-2020-00006
• Device Sequence Number: 1
• Product Code: DQY
• UDI-Device Identifier: 00814548016658
• UDI-Public: 00814548016658
• Combination Product (y/n): Y
• PMA/PMN Number: K152840
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup
• Report Date: 01/01/2005,12/15/2019

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: Health Professional
• Device Model Number: PXSLIMLAN135T45
• Device Catalogue Number: PXSLIMLAN135T45
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/19/2019
• 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: 12/15/2019
• Initial Date FDA Received: 01/07/2020
• Supplement Dates Manufacturer Received: 01/17/2020
• Supplement Dates FDA Received: 02/16/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 75 YR