MAUDE Adverse Event Report: PENUMBRA, INC. NEURON DELIVERY CATHETER 053; DQY

Catalog Number PND6F1056M

Device Problems Break (1069); Difficult To Position (1467); Device Slipped (1584); Detachment of Device or Device Component (2907)

Patient Problem No Information (3190)

Event Date 01/03/2014

Event Type  Injury  

Manufacturer Narrative

Conclusion: the manufacturer received additional information providing the device lot number.No further information is available and the manufacturer is closing its file.The manufacturing records for this lot were reviewed and did not reveal any outstanding discrepancies, design, or quality concerns.

Manufacturer Narrative

Result: the neuron delivery catheter 053 is fractured approximately 89.5 cm from the hub.The distal tip of the catheter is flattened.There are kinks approximately 3.0 and 5.0 cm from the distal tip.Conclusion: the complaint has been evaluated.The complaint indicates that the neuron delivery catheter 053 was used to complete an aneurysm embolization with coils.Once the neuron delivery catheter 053 was withdrawn the distal segment stayed in the body.Evaluation of the returned device confirmed a fracture in the catheter shaft approximately 89.5 cm from the hub.This fracture did not occur at a junction location.The distal tip was also flattened, and there were kinks in the distal tip.It appears that during the procedure, upon withdraw of the device from the patient after successful treatment; the force placed on the device was in excess of the tensile strength specification of the material, causing the material to fracture.These devices are 100% visually inspected for damage during packaging.In addition, all lots are tested for tensile strength and all tested units passed for the tensile strength specification.The flattened and kinked sections of the catheter were likely due to handling after the device was removed from the patient.

Event Description

The patient was undergoing an embolization procedure using a neuron delivery catheter 053.During the procedure, the physician used a st.Jude 035 260 cm guide wire to place the neuron delivery catheter 053; however, did not succeed.The neuron reportedly slipped down therefore a v18 300 cm guide wire was used to sit the neuron 053 with a cook 5f h1 in the left internal carotid artery successfully.The physician was then able to complete the emobolization procedure.The process was smooth.After the embolization, the physician withdrew the neuron delivery catheter 053 and found the distal segment of the catheter stayed in the common carotid and did not come out with the rest of the catheter.The physician snared the detached distal segment into the groin and resheathed it using a 10f sheath together with 150/035 terumo wire.The procedure was completed.

• Brand Name: NEURON DELIVERY CATHETER 053
• Type of Device: DQY
• Manufacturer (Section D): PENUMBRA, INC.; 1351 harbor bay parkway; alameda CA 94502
• Manufacturer (Section G): PENUMBRA, INC.; 1351 harbor bay parkway; alameda CA 94502
• Manufacturer Contact: kathleen kidd ; 1351 harbor bay parkway; alameda, CA 94502 ; 5107483200
• MDR Report Key: 3776773
• MDR Text Key: 11817399
• Report Number: 3005168196-2014-00251
• Device Sequence Number: 1
• Product Code: DQY
• Combination Product (y/n): N
• Reporter Country Code: MC
• PMA/PMN Number: K070970
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,User Facility,Distributor
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 03/29/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/28/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Physician
• Device Expiration Date: 08/31/2016
• Device Catalogue Number: PND6F1056M
• Device Lot Number: F37491
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/07/2014
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 05/08/2014
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/07/2013
• 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