MAUDE Adverse Event Report: CORDIS CORPORATION CATH MB 5F PIG 110CM 6SH; CATHETER, INTRAVASCULAR, DIAGNOSTIC

Catalog Number 532598B

Device Problem Detachment Of Device Component (1104)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 09/01/2017

Event Type  malfunction  

Manufacturer Narrative

(b)(4).A review of the manufacturing documentation associated with this lot 17658579 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.Additional information is pending and will be submitted upon receipt.

Event Description

The catheter was utilized during an emergency aaa procedure to help calibrate the length of the medtronic aaa limbs.During this process the mb 5f pig 110 cm 6sh catheters markers shifted and moved.A total of three catheters were used and the same thing occurred.Finally the last one broke in half.Fortunately, it was successfully retrieved out of the patient with no consequence.A fourth mb catheter was opened and used successfully used with no issues.It was a different lot than the first three.I will be returning twenty (20) each of the affected lot for review.There was no patient injury.There were no anomalies noted when removed from the package.No anomalies were noted during prep.The intended procedure was aaa.The vessel had a little tortuosity and was not calcified.Vessel had a little angulation and had no percentage of stenosis.The device was not used for a chronic total occlusion (total occlusion >3 months).No resistance was met while advancing the device.Excessive torquing was not required.The device did not kink in the area of separation.Resistance was met while withdrawing the device.The segment was retrieved by snaring.The patient is alive and well.Additional procedural details were requested but are unknown.Additional information was received indicating that twenty five (25) catheters were received, two (2) of which were received in two (2) pieces.

Manufacturer Narrative

After further review of additional information received the sections have been updated accordingly.The catheter was utilized during an emergency aaa procedure to help calibrate the length of the medtronic aaa limbs.During this process the mb 5f pig 110cm 6sh catheters markers shifted and moved.A total of three catheters were used and the same thing occurred.Finally the last one broke in half.Fortunately, it was successfully retrieved out of the patient with no consequence.A fourth mb catheter was opened and used successfully used with no issues.It was a different lot than the first three.I will be returning twenty (20) each of the affected lot for review.There was no patient injury.There were no anomalies noted when removed from the package.No anomalies were noted during prep.The intended procedure was aaa.The vessel had a little tortuosity and was not calcified.Vessel had a little angulation and had no percentage of stenosis.The device was not used for a chronic total occlusion (total occlusion >3 months).No resistance was met while advancing the device.Excessive torquing was not required.The device did not kink in the area of separation.Resistance was met while withdrawing the device.The segment was retrieved by snaring.The patient is alive and well.Additional procedural details were requested but are unknown.Additional information was received indicating that twenty five (25) catheters were received, two (2) of which were received in two (2) pieces.One bag with four non-sterile units cath mb 5f pig 110cm 6sh were received coiled.Unit #2 was documented under this complaint.Visual analysis was performed and it was observed separated from the tip of the catheter.The tip of the catheter was not received.Dimensional analysis was performed to verify the correct id and od, measurements were taken at three different places close to the separation section of the catheter according the specification.Dimensional analysis results were found within specification.This measurements were taken from the body of the catheter, the tip section of the catheter could not be measured as it was not received.Microscopic analysis was performed during the sem analysis.The separated surface was scanned to identify the possible root cause of the separation.As it can be observed, material deformation and evidence of elongations were found at the surrounding areas of the separation.The functional test was not performed due to the separated condition of the unit as was received.A device history record (dhr) review of lot 17658579 revealed no anomalies or non-conformances during the manufacturing and inspection processes that can be associated with the reported event.The reported ¿diagnostic catheters marker band (supertorque) offset/out of position¿ and ¿catheter (body/shaft) separated in patient¿ was confirmed through analysis of the returned device referenced as unit #1.However, the exact cause of this condition could not be conclusively determined during the analysis.The complaints were not confirmed for any of the sterile units provided.The reported ¿diagnostic catheters marker band (supertorque) offset/out of position¿ was confirmed through analysis of the returned device referenced as unit #4; however, it was not confirmed through analysis of the returned device referenced as unit #3.However, the exact cause of this condition could not be conclusively determined during the analysis.The reported ¿catheter (body/shaft)-separated¿ was confirmed through analysis of the returned device referenced as unit #2.However, the exact cause of this condition could not be conclusively determined during the analysis.Based on the limited information available for review, procedural/handling factors likely contributed to the separations and marker band movement as evidenced by the elongations noted on the catheter and the plastic deformation noted on the separated catheters during sem analysis.As warned in the instructions for use (ifu), which is not intended as a mitigation, ¿failure to observe these instructions may result in damage, breakage or separation of the catheter or the markerbands, which may necessitate additional intervention.Manipulation of the catheter under excessive friction due to interaction with other devices or while trapped in the vasculature, can lead to stretching or elongation of the catheter.Stretching or elongation of the catheter during endovascular procedures could result in the marker bands moving along the catheter.In extreme cases, marker bands may come off the catheter and dislodge into the vascular system.Avoid excessive tension on the device during manipulation.Extreme care to avoid stretching or elongation must be exercised during manipulation and withdrawal.If resistance is felt during manipulation, determine the cause of resistance before proceeding and confirm super torque mb angiographic catheter positioning under high quality fluoroscopic observation.¿ neither the dhrs nor the product analyses suggest that the reported failures could be related to the manufacturing process.Therefore, no corrective or preventive actions will be taken at this time.

• Brand Name: CATH MB 5F PIG 110CM 6SH
• 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 lakes FL 33014
• Manufacturer Contact: karla castro ; 14201 nw 60th ave; miami lakes, FL 33014
• MDR Report Key: 7004726
• MDR Text Key: 92180762
• Report Number: 9616099-2017-01555
• 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
• Reporter Occupation: Health Professional
• Type of Report: Initial,Followup
• Report Date: 11/23/2017

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 Catalogue Number: 532598B
• Device Lot Number: 17658579
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/08/2017
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 10/08/2017
• Initial Date FDA Received: 11/06/2017
• Supplement Dates Manufacturer Received: 11/06/2017
• Supplement Dates FDA Received: 11/23/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/29/2017
• 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): Hospitalization; Life Threatening; Required Intervention