MAUDE Adverse Event Report: CATH TEMPO 5F UF 65CM 5SH; CATHETER, INTRAVASCULAR, DIAGNOSTIC

Model Number 451504V5

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Vascular Dissection (3160)

Event Date 08/19/2020

Event Type  malfunction  

Manufacturer Narrative

A review of the device history record (dhr) associated with lot 17955606 revealed no anomalies during the manufacturing and inspection processes that can be associated with the reported event.Additional information is pending and will be sent in upon 30 days after receipt.

Event Description

As reported, the physician took the universal flush up and over and into the iliac where he pulled back the unknown wire and noted that the catheter of a 5f 65cm 5 side holes (5sh) tempo diagnostic catheter sprung back to its original shape and dissected the artery.The patient required a stent to be placed into the artery for the dissection.The device was properly stored and opened in sterile field.The device was used in patient.The device was stored in the procedure room for under one month.The device was stored, handled and prepped according to the instructions for use (ifu).There was no difficulty experienced in prepping the device.There were no anomalies noted to the device when it was taken out of the packaging.There were no difficulties removing the product from the packaging.The catheter did not kink or bend at any time prior to resistance/friction.There was no unusual force used at anytime.The product will not be returned as it was discarded.

Manufacturer Narrative

After further review of additional information received the following sections g4,g7,h2 and h6 have been updated accordingly.As reported, the physician took the universal flush up and over and into the iliac where he pulled back the unknown wire and noted that the 5f 65cm 5 side holes (5sh) tempo diagnostic catheter sprung back to its original shape and dissected the artery.The patient required a stent to be placed into the artery for the dissection.The device was properly stored and opened in sterile field.The device was used in the patient.The device was stored in the procedure room for under one month.The device was stored, handled, and prepped according to the instructions for use (ifu).There was no difficulty experienced in prepping the device.There were no anomalies noted to the device when it was taken out of the packaging and there were no difficulties removing the product from the packaging.The catheter did not kink or bend at any time prior to resistance/friction.There was no unusual force used at anytime.The product was not returned for analysis as it was discarded.A product history record (phr) review of lot 17955606 revealed no anomalies or non-conformances during the manufacturing and inspection processes that can be associated with the reported event.Without procedural films or imaging, ¿iliac artery dissection¿ cannot be confirmed, and the exact cause cannot be determined based on the information provided.Dissection is a well-known and extensively documented potential complication of a percutaneous intervention.The physical manipulation inherent in this type of procedure can disrupt the vessel plaque and intima.Vessel characteristics such as calcified lesions or tortuous vessels or procedural/handling factors can contribute to a dissection occurring.According to the instructions for use (ifu), which is not intended as a mitigation of risk, ¿procedures requiring percutaneous catheter introduction should not be attempted by physicians unfamiliar with the possible complications.Complications may occur at any time during or after the procedure.Possible complications include but are not limited to the following: air embolism, hematoma at the puncture site, infection, and perforation of the vessel wall.¿ the recommended procedure states ¿introduce the catheter into the blood vessel using a vascular entry technique of choice.Ptfe coated guidewires are recommended for use with cordis angiographic catheters.Exercise care when removing guidewires from multiple-curve catheters.To prevent kinking of 5f (1.65 mm) and smaller angiographic catheters; straighten the pigtail catheter tip only with a diagnostic guidewire or, if applicable, with a tip straightener.Do not straighten by hand.Use a guidewire when introducing the catheter through the catheter sheath introducer (csi) and into the left ventricle.Treat all 4f 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 phr review nor the information available suggests that the reported event could be related to the manufacturing process of the unit.Therefore, no corrective or preventative actions will be taken at this time.

• Brand Name: CATH TEMPO 5F UF 65CM 5SH
• Type of Device: CATHETER, INTRAVASCULAR, DIAGNOSTIC
• MDR Report Key: 10528424
• MDR Text Key: 206768123
• Report Number: 9616099-2020-03903
• Device Sequence Number: 1
• Product Code: DQO
• UDI-Device Identifier: 20705032008324
• UDI-Public: 20705032008324
• Combination Product (y/n): N
• PMA/PMN Number: K973401
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Type of Report: Initial,Followup
• Report Date: 10/06/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 05/31/2023
• Device Model Number: 451504V5
• Device Catalogue Number: 451504V5
• Device Lot Number: 17955606
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 08/19/2020
• Initial Date FDA Received: 09/14/2020
• Supplement Dates Manufacturer Received: 10/02/2020
• Supplement Dates FDA Received: 10/06/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/26/2020
• 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
• Treatment: UNK WIRE
• Patient Outcome(s): Required Intervention
• Patient Age: 71 YR