MAUDE Adverse Event Report: CORDIS CORPORATION SUPERTORQUE 5F MARKER BAND FLUSH CATHETER; DIAGNOSTIC ENDOVASCULAR CATHETERS (DQO)

Model Number 532598C

Device Problem Detachment Of Device Component (1104)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 11/17/2014

Event Type  malfunction  

Event Description

The report received indicated that the 5f pig 65cm super torque catheter broke completely half way up catheter below last marker when being manipulated in aorta of patient over a wire through femoral approach.The catheter was removed without injury to the patient and catheter was saved for inspection.

Manufacturer Narrative

The gender of the patient is unknown.This device is available for analysis but has not yet been received.Additional information is pending and will be submitted within 30 days upon receipt.

Manufacturer Narrative

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.This device is available for analysis but the engineering report is not yet available.However, it will be submitted within 30 days upon receipt.

Manufacturer Narrative

The complaint product was returned for evaluation.This device is available for analysis but the engineering report is not yet available.However, it will be submitted within 30 days upon receipt.

Manufacturer Narrative

Complaint conclusion: the report received indicated that the 5f pig 65cm super torque catheter broke completely half way up the catheter below the last marker when being manipulated in the aorta of patient over a wire via femoral approach.The catheter was removed without injury to the patient and catheter was saved for inspection.The lesion was moderately tortuous and moderately angled.There was no stenosis.The catheter shaft proximal to the markers separated in two pieces in the patient.The separated segment was retrieved carefully by exchanging for a larger sheath and pulling out the same wire.The patient is currently ¿well.¿ the device was used in an abdominal aortic aneurysm (aaa) procedure.The device was not resterilized.There were no anomalies noted when the device was removed from the package and during prep.The device was not inserted through a stopcock instead of a hemostatic valve.A terumo glide wire was used for the case.There was no resistance met while advancing the device to the lesion or advancing the device over the guide wire.Excessive torquing was not required.The device did not kink in the area of separation.¿normal resistance¿ was met while withdrawing the device.A non-sterile diagnostic catheter cath mb 5f pig 65cm 8sh was received for analysis coiled inside a plastic bag.Per visual analysis, the catheter was received separated at 25.0 cm from distal tip.The unit was inspected under vision system and separation edges exhibited damages on the body surface of catheter and separation showed elongation characteristics at the separation point.Also, a kinked condition was found on the body shaft of catheter at 24.3 cm from hub.No other anomalies observed.The catheter od and id were measured near to the kink and separation conditions and results were found within specification.Sem analysis was performed to the received unit with the following results: results showed that the body presented elongations and deformations induced by tension.The elongations observed presented evidence of a plastic deformation as a product of an application of a tension force that induced the separation.No other anomalies were found during sem analysis.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.The reported ¿diagnostic endovascular catheters-catheter (body/shaft)- separated-in patient¿ was confirmed due to the separated condition of catheter as received.However, the cause of the kink and separation conditions found could not be conclusively determined during the analysis.Based on the information available for review, factors contributing to the separation could not be determined; however, the returned device presented with kinking and elongation at the point of separation which may indicate that force was applied at some point.The cause of these damages do not appear to be related to the design or manufacturing process; therefore, no corrective action will be taken at this time.

Manufacturer Narrative

Additional information was provided by the sales representative.The catheter shaft proximal to the markers separated in two pieces in the patient.The separated segment was retrieved carefully by exchanging for a larger sheath and pulling out the same wire.The patient is currently ¿well.¿ the device was used in an abdominal aortic aneurysm (aaa) procedure.The patient was male.The lesion was moderately tortuous and moderately angled.There was no stenosis.The device was not resterilized.There were no anomalies noted when the device was removed from the package and during prep.The device was not inserted through a stopcock instead of a hemostatic valve.A terumo glide wire was used for the case.There was no resistance met while advancing the device to the lesion or advancing the device over the guide wire.Excessive torquing was not required.The device did not kink in the area of separation.¿normal resistance¿ was met while withdrawing the device.This device is available for analysis but the engineering report is not yet available.However, it will be submitted within 30 days upon receipt.

• Brand Name: SUPERTORQUE 5F MARKER BAND FLUSH CATHETER
• Type of Device: DIAGNOSTIC ENDOVASCULAR CATHETERS (DQO)
• Manufacturer (Section D): CORDIS CORPORATION; 14201 nw 60th avenue; miami lakes FL
• Manufacturer Contact: cecil navajas ; circuito interior norte #1820; juarez chihuahua 32580 ; MX 32580 ; 7863133880
• MDR Report Key: 4296397
• MDR Text Key: 5193408
• Report Number: 9616099-2014-00775
• Device Sequence Number: 1
• Product Code: DQO
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K915836
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative
• Reporter Occupation: Health Professional
• Type of Report: Initial,Followup,Followup,Followup,Followup
• Report Date: 01/08/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/04/2014
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 07/31/2017
• Device Model Number: 532598C
• Device Catalogue Number: 532598C
• Device Lot Number: 17093238
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/08/2014
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/08/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/25/2014
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1