MAUDE Adverse Event Report: CORDIS DE MEXICO CATH TEMPO 4F UF 65CM 5SH; DIAGNOSTIC CATHETER

Model Number N/A

Device Problem Detachment Of Device Component (1104)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 03/29/2017

Event Type  malfunction  

Manufacturer Narrative

The device was returned but the engineering report is pending. a device history record review was performed and showed that these lots of products met all requirements per the applicable manufacturing quality plan.  additional information is pending and will be submitted within 30 days upon receipt.

Event Description

As reported, the tip of the catheter broke off in the sheath.It is unknown when the failure occurred during the case.There was no reported patient injury.The device is available for return.

Manufacturer Narrative

As reported, the tip of the catheter broke off in a non-cordis 6f sheath introducer approximately 1 inch from the distal end.The sheath and separated tip were removed as a unit.The procedure was completed by using a new sheath, wire and catheter and started over.There was no reported patient injury.The guidewire used was a 0.035" 180cm non-cordis glidewire.The lesion was at least 50% occluded and with moderate calcification.There were no anomalies noted when the device was removed from the package or during prep.The procedure being performed was an aortagram, angioplasty.There was no resistance met while advancing the device and no excessive torquing required.There was no resistance met while advancing the device over the guidewire.Resistance was met while withdrawing the device and excessive force was used to withdraw the device.The physician had to remove sheath and wire as well.A non-sterile cath tempo 4f uf 65cm 5sh diagnostic catheter along with an unknown catheter sheath was received for analysis coiled inside a plastic bag.The brite tip/distal tip of catheter was received detached/ separated at 56.3 cm from id band.The sheath was received kinked at 3.8 cm from hub and distal tip frayed/prolapsed damage.Per visual analysis, the received separated tip of the diagnostic catheter was observed twisted/damaged (the separated edges on received separated unit look as if tremendous force was applied until break/separation occurred on distal tip).Also, the distal section of the diagnostic catheter unit (where separation occurred) was inspected under vision system and evidence of elongations was observed.Elongations found suggest that the catheter was induced to an excess of torsion/ force applied that could cause the damage found.Id and od of catheter were measured near the separated area and results were found within specifications.Per microscopic analysis, evidence of transfer of material between separated parts could be observed.Also, external edge surfaces at separation area was observed and it showed clear evidence of elongations at separation.Elongations characteristics present evidence of an application of a tension force that induced the cannula body separation.A device history record (dhr) review of lot 17631469 revealed no anomalies or non-conformances during the manufacturing and inspection processes that can be associated with the reported event.The reported ¿brite tip/distal tip ¿ catheters-separated¿ was confirmed through analysis of the returned device.However, the exact cause of the separated/elongated conditions found on the unit could not be conclusively determined during the analysis.Based on the information available for review, procedural/handling factors may have contributed to the distal tip catheter separation reported as evidenced by the twisted and elongated damage noted at the separation site with transfer of material observed.According to the instructions for use (ifu), ¿treat all 4f (1.35 mm) catheters and smaller french sizes with ultimate care.The performance of these products may be impaired if not properly and cautiously handled during unpacking and preparation.¿ 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 TEMPO 4F UF 65CM 5SH
• Type of Device: DIAGNOSTIC CATHETER
• Manufacturer (Section D): CORDIS DE MEXICO; circuito int nte 1820; juarez 32575 ; MX 32575
• Manufacturer (Section G): CORDIS DE MEXICO; circuito int nte 1820; juarez 32575 ; MX 32575
• Manufacturer Contact: cecil navajas ; 14201 nw 60th ave; miami lakes, FL 33014
• MDR Report Key: 6513078
• MDR Text Key: 73461109
• Report Number: 9616099-2017-01049
• Device Sequence Number: 1
• Product Code: DQO
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K973401
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Health Professional
• Type of Report: Initial,Followup
• Report Date: 05/11/2017

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 Model Number: N/A
• Device Catalogue Number: 451404V5
• Device Lot Number: 17631469
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/07/2017
• Is the Reporter a Health Professional?: Yes
• Distributor Facility Aware Date: 03/29/2017
• Initial Date Manufacturer Received: 03/29/2017
• Initial Date FDA Received: 04/21/2017
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 05/11/2017
• 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: N
• Patient Sequence Number: 1