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

Catalog Number 532598A

Device Problems Detachment Of Device Component (1104); Difficult to Remove (1528)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 09/05/2017

Event Type  malfunction  

Manufacturer Narrative

Additional information is pending and will be submitted within 30 days upon receipt.

Event Description

As reported, the 5f pig catheter 110 cm 6sh broke inside a cordis sheath.The user had seen the catheter ¿free into the artery¿ and pulled it with more force when the catheter broke.The user removed the catheter and the wire together and the sheath introducer was changed.When the catheter was checked, it was noted that two (2) markers were not on it but rather inside the introducer.Another two (2) gold distal markers moved from the initial position on the catheter.There was no reported patient injury.The device was stored and handled per the instructions for use (ifu).The product was prepped properly according to the ifu.The device was prep normally and the catheter was not re-shaped by the user.There were no kinks or other damages noted prior to inserting the product into the patient.The catheter tip was visible on fluoro throughout the procedure.There was no difficulty tracking the catheter through the vessel or lesion.The catheter was not torqued against resistance.There was no part of the catheter separated.The two distal markers moved from the original position but they stayed on the catheter without migrating inside the patient.

Manufacturer Narrative

After further review of additional information received the sections have been updated accordingly.As reported, the 5f pig catheter 110cm 6sh broke inside a cordis sheath.The user had seen the catheter ¿free into the artery¿ and pulled it with more force when the catheter broke.The user removed the catheter and the wire together and the sheath introducer was changed.When the catheter was checked, it was noted that two (2) markers were not on it but rather inside the introducer.Another two (2) gold distal markers moved from the initial position on the catheter.There was no reported patient injury.The device was stored and handled per the instructions for use (ifu).The product was prepped properly according to the ifu.The device was prep normally and the catheter was not re-shaped by the user.There were no kinks or other damages noted prior to inserting the product into the patient.The catheter tip was visible on fluoro throughout the procedure.There was no difficulty tracking the catheter through the vessel or lesion.The catheter was not torqued against resistance.There was no part of the catheter separated.The two distal markers moved from the original position but they stayed on the catheter without migrating inside the patient.A non-sterile diagnostic cath mb 5f pig 110cm 6sh was received for analysis coiled inside a plastic bag.The concomitant catheter sheath introducer mentioned on the event description was not returned for analysis.The diagnostic catheter unit was received separated at 19.5cm from distal tip.Per visual analysis, 16 marker bands out of the 20 remained in their original place on the separated portion of unit, 2 marker bands were observed moved/out of position.The other two marker bands were missing (not returned for analysis).The distal section of the unit was observed under vision system and the marker band marks on the unit¿s surface did not present evidence of damage (scratches, peelings, abrasions, etc.).However, an elongation was observed from 86.0 to 90.5 cm from hub.The elongated length measured 4.5cm.No other anomalies were found.The catheter¿s id and od in the sections near the separated areas, and between the marker bands near the elongation area were measured.Results were found out of specification, except for the measurements near the distal separated section.It can be assured that the marker bands were placed on the correct position at a certain time owing to the outer diameter reduction of the body.Per functional analysis, a pull test was not performed as no sterile unit was returned.Also, a guidewire could not be inserted through the catheter due to the separated condition of the received unit.Per microscopic analysis, the separated sections of the unit were reviewed under vision system and evidence of elongations and plastic deformations on both frayed edges were found.These characteristics are clear evidence of an application of a high-tension force that induced the separation for the product.No other issues were noted during the microscopic analysis.A device history record (dhr) review could not be performed since the complaint lot is unknown.The reported ¿catheter (body/shaft)- separated¿, ¿catheter (body/shaft)- withdrawal difficulty¿, ¿marker band (supertorque)- offset/out of position¿ & ¿marker band (supertorque)- dislodged¿ were confirmed through analysis of the returned device.The exact cause of the separation and out of position marker bands on the unit could not be conclusively determined during the analysis.Based on limited information available for review, procedural and handling factors (the unit was pulled with force through the catheter sheath) likely contributed to the event reported as evidenced by the elongations noted on the catheter and the plastic deformations (frayed edges) at the site of separation.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.¿ additionally, diagnostic catheter controls are in place to verify the catheters for marker bands defects.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 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 ave; miami lakes FL
• Manufacturer (Section G): CORDIS CORPORATION; 14201 nw 60th ave; miami lakes FL 33014
• Manufacturer Contact: karla castro ; 14201 nw 60th ave; miami lakes, FL 33014
• MDR Report Key: 6952470
• MDR Text Key: 90460341
• Report Number: 9616099-2017-01513
• Device Sequence Number: 1
• Product Code: DQO
• Combination Product (y/n): N
• Reporter Country Code: IT
• PMA/PMN Number: K915836
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 11/15/2017

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 Catalogue Number: 532598A
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/05/2017
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 09/20/2017
• Initial Date FDA Received: 10/16/2017
• Supplement Dates Manufacturer Received: 10/30/2017
• Supplement Dates FDA Received: 11/15/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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