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

Model Number 451504V5

Device Problems Difficult to Remove (1528); Sticking (1597); Unraveled Material (1664)

Patient Problems Claudication (2550); Vascular Dissection (3160)

Event Date 07/13/2016

Event Type  Injury  

Event Description

It was reported that a non-cordis 0.35 guidewire and a 5f tempo catheter was removed and caused a dissection to the right external iliac artery extending down to the common femoral.The patient received 3 covered stent in the lesion to rectify the vessel dissection and patient was discharged with no extended stay.The non-cordis 0.35 guidewire was advanced through a 5f tempo catheter for abdominal angiogram.When the physician attempted to remove the guide wire, the guidewire was stuck in the catheter and it unraveled inside the catheter.The physician was concern that there will be fragments of the guidewire left in the catheter so the physician withdrew the device and the guidewire together which resulted in a dissection to the right external iliac artery extending down to the common femoral.After the device were removed, the guidewire was still intact inside the catheter, however, it was unraveled.Both the device will be returned for analysis.The patient was suffering from claudication symptoms.

Manufacturer Narrative

It was reported that a non-cordis 0.35 guidewire and a 5f tempo catheter was removed and caused a dissection to the right external iliac artery extending down to the common femoral.The patient received 3 covered stent in the lesion to rectify the vessel dissection and patient was discharged with no extended stay.The non-cordis 0.35 guidewire was advanced through a 5f tempo catheter for abdominal angiogram.When the physician attempted to remove the guide wire, the guidewire was stuck in the catheter and it unraveled inside the catheter.The physician was concern that there will be fragments of the guidewire left in the catheter so the physician withdrew the device and the guidewire together which resulted in a dissection to the right external iliac artery extending down to the common femoral.After the device were removed, the guidewire was still intact inside the catheter, however, it was unraveled.Both the device will be returned for analysis.The patient was suffering from claudication symptoms.One non-sterile unit from product cath tempo 5f uf 65cm 5sh was received coiled inside of a plastic bag; also a non cordis guide wire was received and its distal section was unraveled\stretched.No anomalies were observed on the received diagnostic catheter.An emerald.035¿ guide wire lab sample was inserted through the five received catheters and no resistance or friction was experienced during the insertion/withdrawal.A device history record review of lot 17425150 was performed and showed that the lot met all requirements per the applicable manufacturing quality plan and that there were no anomalies during the manufacturing.The failure ¿catheter (body/shaft) ¿ resistance/friction - inner lumen¿ was not confirmed, since functional analysis was performed without any difficulty on the received catheter, no resistance/friction was felt during the guide wire insertion/withdrawal.The cause of the reported event could not be conclusively determined, since no anomalies were observed on the received device.According to the instruction for use.Slide the removable pigtail straightener forward to open pigtail.Straighten the pigtail; insert the guidewire.Remove the pigtail straightener by pulling it back and peeling it away, or leave it on the strain relief of the catheter.Start with peeling away from the proximal end.Notes: the pigtail straightener is not to be used as a vascular introducer sheath.The pigtail straightener also snap-fits to cordis 4f and 5f sheath introducers.Remove the pigtail straightener directly.Dissection is a well-known and extensively documented potential complication of this type of procedure and is listed in the instructions for use (ifu) as such.Vessels that are resistant to angioplasty have a higher risk of intimal dissection during interventional procedures.There is no evidence to suggest there were any manufacturing issues that contributed to the reported event.This does not represent device malfunction.Based on the available information there is no evidence to suggest that the event was design or manufacturing related.Neither the dhr review nor the product analysis results suggests that the reported failures could be related to the manufacturing process of the unit.Therefore no corrective action will be taken.

• Brand Name: CATH TEMPO 5F UF 65CM 5SH
• Type of Device: TEMPO 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
• MDR Report Key: 6056880
• MDR Text Key: 58402101
• Report Number: 9616099-2016-00685
• 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
• Reporter Occupation: Health Professional
• Type of Report: Initial,Followup
• Report Date: 11/22/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/26/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: No
• Device Operator: No Information
• Device Expiration Date: 01/31/2019
• Device Model Number: 451504V5
• Device Catalogue Number: 451504V5
• Device Lot Number: 17425150
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/12/2016
• Is the Reporter a Health Professional?: Yes
• Distributor Facility Aware Date: 09/16/2016
• Date Manufacturer Received: 09/16/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/03/2016
• Is the Device Single Use?: Yes
• Type of Device Usage: N
• Patient Sequence Number: 1