MAUDE Adverse Event Report: CORDIS CORPORATION CATH F6INF TL JR 4 100CM; CATHETER, INTRAVASCULAR, DIAGNOSTIC

Model Number 532X

Device Problems Detachment Of Device Component (1104); Inaccurate Dispensing (2955)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 09/19/2017

Event Type  Injury  

Manufacturer Narrative

(b)(4).A review of the manufacturing documentation associated with this lot presented no issues during the manufacturing process that can be related to the reported complaint.Review of lot 17653067 revealed no anomalies during the manufacturing and inspection processes that can be associated with the reported complaint.The product has been returned for evaluation and testing; however, the engineering evaluation has not been completed.Additional information will be submitted within 30 days of receipt.

Event Description

When withdrawing an infiniti angiographic catheter (f6 tl jr 4 100cm), it was reported that the catheter spontaneously fractured in its proximal segment (8.8 cm, at the welding point between shaft and shaped tip) and migrated into the abdominal aorta.The fragment was later retrieved through right femoral access (10 f introducer, 20 mm snare).Fortunately, no clinical consequences for the patient at the time being.The fracture line does not look neat, but jagged and the two pieces seems to be complementary.Initially, the device was positioned in ascending aorta through right radial access (without any inconvenience and without any torsion or traction of the device).It was noted that the event was reported to the (b)(4) affiliate on (b)(4) 2017.Several attempts to gather additional information have been made and have been unsuccessful.

Manufacturer Narrative

When withdrawing an infiniti angiographic catheter (6f tl jr 4 100 cm), it was reported that the catheter spontaneously fractured in its proximal segment (8.8 cm, at the welding point between shaft and shaped tip) and migrated into the abdominal aorta.The fragment was later retrieved through right femoral access (10 f introducer, 20 mm snare).Fortunately, no clinical consequences for the patient at the time being.The fracture line does not look neat, but jagged and the two pieces seems to be complementary.The catheter is currently stored at the customer facility.All the units belonging to the same lot have been identified and put aside (for a total of 58 units).Initially, the device was positioned in ascending aorta through right radial access (without any inconvenience and without any torsion or traction of the device).Several attempts to gather additional information have been made and have been unsuccessful.A non-sterile diagnostic cath f6inf tl jr 4 100 cm was received for analysis inside a plastic bag.Per visual analysis, the catheter¿s body presented a separation at 9 cm from distal section.Dried blood residues were observed on catheter distal tip section.No other damages were found.Per dimensional analysis, the catheter¿s outer diameter/inner diameter was measured near the separation area and the results were found within specification.Sem analysis was required to determine the root cause of the catheter¿s distal section separation and results showed that the separated areas presented material deformation, evidence of elongations, and frayed edges.These characteristics suggest that the device was induced to stretching/pulling events that exceeded the material¿s yield strength prior to the separation.No other issues were noted during sem analysis.The reported ¿catheter (body/shaft) separated in patient¿ was confirmed through analysis of the returned device.The exact cause of the separated condition found on catheter body could not be conclusively determined during the analysis.Based on the limited information available for review, procedural and handling factors likely contributed to the separation reported as evidenced by the material deformation, elongations, and frayed edges noted during sem analysis.As cautioned instruction for use, which is not intended as a mitigation, ¿to prevent damage to the catheter tip during removal from the package, grasp the hub and withdraw the catheter.Exercise care when removing guidewires from multiple-curve catheters.To prevent kinking of 5f (1.65 mm) and smaller angiographic catheters, and specifically the 4f (1.35 mm) infiniti® pigtail catheters: straighten the pigtail catheter tip only with a diagnostic guidewire or, if applicable, with a tip straightener.Do not straighten by hand.Use a guidewire when introducing the catheter through the catheter sheath introducer (csi) and into the left ventricle.¿ controls are in place to verify the catheters this kind issue; the produced diagnostic catheters are inspected 100% before leaving the facility.Also, several inspections are performed through all the diagnostic catheter assembly process operations.Neither the dhr review nor the product analysis suggests that the event experienced by the customer could be related to the manufacturing process; therefore, no corrective/preventive action will be taken.

• Brand Name: CATH F6INF TL JR 4 100CM
• Type of Device: CATHETER, INTRAVASCULAR, DIAGNOSTIC
• Manufacturer (Section D): CORDIS CORPORATION; 14201 nw 60th avenue; miami lakes FL 33014
• Manufacturer (Section G): CORDIS CORPORATION; 14201 nw 60th avenue; miami FL 33152
• Manufacturer Contact: karla castro ; 14201 nw 60th ave; miami lakes, FL 33014
• MDR Report Key: 6950863
• MDR Text Key: 89366421
• Report Number: 1016427-2017-00691
• Device Sequence Number: 1
• Product Code: DQO
• Combination Product (y/n): N
• Reporter Country Code: IT
• PMA/PMN Number: K970854
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 11/02/2017

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 Expiration Date: 02/29/2020
• Device Model Number: 532X
• Device Catalogue Number: 532X
• Device Lot Number: 17653067
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/06/2017
• Is the Reporter a Health Professional?: Yes
• Distributor Facility Aware Date: 09/19/2017
• Initial Date Manufacturer Received: 09/19/2017
• Initial Date FDA Received: 10/16/2017
• Supplement Dates Manufacturer Received: 10/23/2017
• Supplement Dates FDA Received: 11/02/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/11/2017
• 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