MAUDE Adverse Event Report: CORDIS CORPORATION CATH NYLEX 4F PIG 100CM 8SH; CATHETER, INTRAVASCULAR, DIAGNOSTIC

Model Number 526412

Device Problems Difficult to Remove (1528); Detachment of Device or Device Component (2907)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 02/03/2022

Event Type  Injury  

Manufacturer Narrative

Complaint conclusion: as reported, when the nylex 4f pig 100cm 8sh catheter was removed from patient the tip of the catheter snapped and needed to be snared.The tip separated approximately 10cm from the distal end.It happened whilst taking the pig catheter off over the wire at the bifurcation.There was slight resistance then a popping sound followed by no resistance.The catheter appeared to shear where the side holes stop.The intended procedure was a superficial femoral artery (sfa) atherectomy and stenting.The procedure was a right up and over approach via the iliac artery.The device was not used for a chronic total occlusion (total occlusion >3 months).The device was not re-sterilized.There were no anomalies noted when removed from the package.There were no anomalies noted during prep.The device was not inserted through a stopcock instead of a hemostatic valve.Resistance was not met while advancing the device.Excessive torquing was not required.Resistance was not met while advancing the device over the guidewire.A coronary balloon was used to trap the piece of the catheter into sheath, and everything was removed.The procedure continued without incident.The product was not returned for analysis as it was discarded.A product history record (phr) review of lot 18039945 revealed no anomalies or non-conformances during the manufacturing and inspection processes that can be associated with the reported event.Without the return of the device or images for analysis, the reported customer event ¿catheter (body/shaft)- separated- in-patient¿ and catheter (body/shaft)-withdrawal difficulty-from vessel could not be confirmed.Vessel characteristics and/or manipulating the catheter against resistance may have contributed to the reported event.Users are trained to inspect for signs of damage prior to and during use.Any product with damage is not to be used.Information for safety is provided in the products labeling with the intent to make the user aware of the risks.According to the instructions for use (ifu), although not intended as a mitigation of risk, ¿to prevent damage to the catheter tip during removal from the package, grasp the hub and gently withdraw the catheter.To prevent kinking of 5f and smaller angiographic catheters, ensure that the pigtail catheter is not straightened by hand, but only with a diagnostic guidewire or, if applicable, with a tip straightener.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.For all catheters: keep the catheter filled with either¿ based on the information available and the phr review, there is no indication that the event is related to the device design or manufacturing process.Therefore, no preventative or corrective actions will be taken at this time.

Event Description

As reported, when the nylex 4f pig 100cm 8sh catheter was removed from patient the tip of the catheter snapped and needed to be snared.The tip separated approximately 10cm from the distal end.It happened whilst taking the pig catheter off over the wire at the bifurcation.There was slight resistance then a popping sound followed by no resistance.The catheter appeared to shear where the sideholes stop.The intended procedure was a superficial femoral artery (sfa) arthrectomy and stenting.The procedure was via a right up and over approach via the iliacs.The device was not used for a chronic total occlusion (total occlusion >3 months).The device was not re-sterilized.There were no anomalies noted when removed from the package.There were no anomalies noted during prep.The device was not inserted through a stopcock instead of a hemostatic valve.Resistance was not met while advancing the device.Excessive torquing was not required.Resistance was not met while advancing the device over the guidewire.A coronary balloon was used to trap the piece of the catheter into sheath, and everything was removed.The procedure continued without incident.The device is not expected to be returned for evaluation as it was discarded.

• Brand Name: CATH NYLEX 4F PIG 100CM 8SH
• Type of Device: CATHETER, INTRAVASCULAR, DIAGNOSTIC
• Manufacturer (Section D): CORDIS CORPORATION; 14201 nw 60 avenue; miami lakes FL 33014
• Manufacturer (Section G): CORDIS CORPORATION; 14201 nw 60 avenue; miami lakes FL 33014
• Manufacturer Contact: karla castro ; 14201 nw 60 avenue; miami lakes, FL 33014 ; 7863138372
• MDR Report Key: 13660463
• MDR Text Key: 287392519
• Report Number: 9616099-2022-05390
• Device Sequence Number: 1
• Product Code: DQO
• UDI-Device Identifier: 20705032010558
• UDI-Public: (01)20705032010558(17)240630(10)18039945
• Combination Product (y/n): N
• Reporter Country Code: AS
• PMA/PMN Number: K971646
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 03/03/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/03/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 526412
• Device Catalogue Number: 526412
• Device Lot Number: 18039945
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/04/2022
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 07/23/2021
• 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: SNARE CATHETER.
• Patient Sex: Male
• Patient Race: White