MAUDE Adverse Event Report: CATH TEMPO 4F UF 65CM 5SH; CATHETER, INTRAVASCULAR, DIAGNOSTIC

Model Number 451404V5

Device Problem Detachment of Device or Device Component (2907)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 08/05/2020

Event Type  malfunction  

Manufacturer Narrative

A device history record review was performed and showed that these lots of products met all requirements per the applicable manufacturing quality plan.This device was received for analysis but the engineering report is not yet available.However, it will be submitted within 30 days upon receipt.

Event Description

As reported, prior to insertion of 4f universal flush (uf) 65cm 5 side holes (sh) tempo diagnostic catheter through the unknown sheath and into the patient, the tempo catheter was being passed over the unknown wire, however, the tip of the catheter separated from the shaft.Device was promptly removed so that the end did not get lost inside the patient.There was no reported patient injury.The physician was carrying out a bilateral iliac in the hybrid theatre.Both common femoral arteries were punctured and had 7fr sheaths inserted.The catheter was flushed by the scrub nurse and handed to the physician prior to doing a run to visualise the iliac's using the injector pump.The physician then put the catheter over a 180cm j starter wire, which advanced half way up the wire.Whilst advancing the catheter over the wire, the tip of the catheter (the curved section of the catheter) came apart from the straight shaft of the catheter, prior to insertion of the sheath.It did not go in the patient.The tip of the catheter and the rest of the catheter were taken off and put to the side for investigation.The device will be returned for analysis.

Manufacturer Narrative

As reported, prior to insertion of the 4f tempo diagnostic catheter through the unknown sheath and into the patient, the tempo catheter was being passed over the unknown wire, however, the tip of the catheter separated from the shaft.The device was promptly removed so that the end did not get lost inside the patient.There was no reported patient injury.The physician was carrying out a bilateral iliac in the hybrid theatre.Both common femoral arteries were punctured and had 7fr sheaths inserted.The catheter was flushed by the scrub nurse and handed to the physician prior to doing a run to visualise the iliacs using the injector pump.The physician then put the catheter over a 180cm j starter wire, which advanced half-way up the wire.Whilst advancing the catheter over the wire, the tip of the catheter (the curved section of the catheter) came apart from the straight shaft of the catheter, prior to insertion of the sheath.It did not go in the patient.The tip of the catheter and the rest of the catheter were taken off and put to the side for investigation.A non-sterile unit of a 4f tempo diagnostic catheter was received for analysis.Per visual analysis, a separated condition was observed on the returned unit located at 58.5 cm from the hub edge.Both segments were returned for analysis.No other damages or anomalies were found.The dimensions of the inner diameter (id) and outer diameter (od) were measured.Measurements were taken at one cm from the separated edge of the two segments.Dimensional analysis results were found within specification.The edges of the separated area were observed under the vision system.The edges of the separated section presented evidence of an accordioned condition, diameter reduction, elongations, and frayed edges.These characteristics suggest that the device was induced to stretching/pulling or twisting events that exceeded the material yield strength prior to the separation.No other issues were noted during microscopic analysis.A product history record (phr) review of lot 35260973 revealed no anomalies or non-conformances during the manufacturing and inspection processes that can be associated with the reported event.The complaint reported by the customer as ¿brite tip/distal tip catheters- separated during prep¿ was confirmed, a separated condition was observed on the body of the returned catheter.Exact cause of the separation could not be conclusively determined during the analysis.The elongations found on the edges of the separated segments suggest that the device was induced to stretching/pulling or twisting events that exceeded the material yield strength prior to the separation.Procedural/handling factors may have contributed to the reported event.According to the instructions for use (ifu), which is not intended as a mitigation of risk, ¿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.Before use, flush all devices entering a blood vessel with sterile heparinized saline or a similar isotonic solution.Keep the catheter filled with either flushing solution or contrast medium while the catheter is in the vascular system and consider the use of systemic heparinization.Forcibly aspirate and flush the catheter with heparinized saline solution at least once every two minutes.Procedures requiring percutaneous catheter introduction should not be attempted by physicians unfamiliar with the possible complications.¿ neither the phr review nor the product analysis suggests that the found conditions could be related to the manufacturing process of the unit.Therefore, no corrective or preventive actions will be taken at this time.

• Brand Name: CATH TEMPO 4F UF 65CM 5SH
• Type of Device: CATHETER, INTRAVASCULAR, DIAGNOSTIC
• MDR Report Key: 10511213
• MDR Text Key: 206314118
• Report Number: 9616099-2020-03896
• Device Sequence Number: 1
• Product Code: DQO
• UDI-Device Identifier: 10705032007733
• UDI-Public: 10705032007733
• 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,foreig
• Type of Report: Initial,Followup
• Report Date: 10/01/2020

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: 12/31/2022
• Device Model Number: 451404V5
• Device Catalogue Number: 451404V5
• Device Lot Number: 17920289
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/03/2020
• Initial Date Manufacturer Received: 08/12/2020
• Initial Date FDA Received: 09/09/2020
• Supplement Dates Manufacturer Received: 09/23/2020
• Supplement Dates FDA Received: 10/01/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/09/2020
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Treatment: UNK SHEATH, UNK WIRE