MAUDE Adverse Event Report: CORDIS CORPORATION CATH F5.2+ PIG 110CM 6SH; CATHETER, INTRAVASCULAR, DIAGNOSTIC

Model Number 533533

Device Problems Crack (1135); Detachment of Device or Device Component (2907); Device-Device Incompatibility (2919)

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

Event Date 06/12/2022

Event Type  malfunction  

Manufacturer Narrative

A review of the manufacturing documentation associated with lot 18046150 presented no issues during the manufacturing process that can be related to the reported event.Additional information is pending and will be submitted within 30 days upon receipt.

Event Description

As reported, the hub of a 5.2f straight pigtail 110cm 6 side hole (sh) super torque plus diagnostic catheter snapped off when a non-cordis high-pressure line was connected to it and actually cracked/broke.The plastic hub at proximal end of catheter snapped when being attached to the flush line.Catheter was removed without further incident.The procedure was completed by inserting a new unknown catheter and a non-cordis pressure tubing was also replaced although not damaged during initial incident.There was no reported patient injury.The case was a st-elevated myocardial infarction (stemi) and this occurred during an attempt to perform a left ventricular (lv) flush study.No obvious external fault identified with catheter prior to use.The device was stored and prepped as per the instructions for use (ifu).There was no resistance met while advancing the device nor excessive torqueing was required.There was no resistance met while withdrawing the device.The device will be returned for evaluation.

Manufacturer Narrative

After further review of additional information received the following sections have been updated accordingly: d8, d9, g3, g6, h1, h2, h3, and h10.This device is available for analysis but the engineering report is not yet available.However, it will be submitted within 30 days upon receipt.Additional information is pending and will be submitted within 30 days upon receipt.

Manufacturer Narrative

Complaint conclusion: as reported, the hub of a 5.2f straight pigtail 110cm 6 side hole (sh) super torque plus diagnostic catheter snapped off when a non-cordis high-pressure line was connected to it and actually cracked/broke.The plastic hub at proximal end of catheter snapped when being attached to the flush line.Catheter was removed without further incident.The procedure was completed by inserting a new unknown catheter and a non-cordis pressure tubing was also replaced although not damaged during initial incident.There was no reported patient injury.The case was a st-elevated myocardial infarction (stemi) and this occurred during an attempt to perform a left ventricular (lv) flush study.No obvious external fault identified with catheter prior to use.The device was stored and prepped as per the instructions for use (ifu).There was no resistance met while advancing the device nor was excessive torquing required.There was no resistance met while withdrawing the device.The device will be returned for evaluation.The device was returned for analysis.A non- sterile ¿cath f5.2+ pig 110cm 6sh" was received coiled inside a clear plastic bag along with an unknown flushing line.The device was unpacked to proceed with the product evaluation.The unit was thoroughly inspected observing that the luer hub presents a separated condition.The separated piece was retuned inside the connector of the unknown flushing line.No other damages or anomalies were observed on the returned product.Dimensional and functional analysis was not performed due to the separated condition of the luer hub.Per sem analysis, a fractured/broken condition was observed on the hub surface noted to the extent along the hub separation surface.The striation patterns observed in the separation border are commonly associated with the elongation behavior caused in polymeric materials due to excessive stress where the resistance properties were overloaded.No other anomalies were observed during sem analysis.The phr review for lot 18046150 does not suggest that the failure experienced by the customer could be related to the manufacturing process.The complaint reported by the customer as ¿luer hub ¿ catheters-cracked¿ was not confirmed during analysis of the returned device.The reported ¿luer hub ¿ catheters-separated¿ was confirmed during analysis of the returned device, as the hub was fractured and separated.Plastic deformation and fatigue striations are commonly associated with separations caused by material tensile overload therefore, it is assumed that the hub material was induced to a tensile force that exceeded the hub material yield strength prior to the separation.There are multiple factors such as storage and handling (incorrect temperature, lighting, and humidity).Procedural and patient factors such as excessive tortuosity of the aorta or a very tight aortic valve which makes crossing the valve very difficult without excessive torquing and manipulation of the catheter, primarily at the hub, in order to cross the valve.Prior to entering the patient¿s body, the luer hub is also attached to a syringe for flushing of the device, excessive force during syringe attachment can also lead to stress and/or fatigue of the luer hub.This all occurs prior to connecting to injection tubing.Although not intended as a mitigation of risk, 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), ¿store in a cool, dark, dry place.Do not use if package is open or damaged.Exposure to temperatures above 54°c (130¿) may damage the catheter.¿ neither the phr review nor the product analysis suggests that the reported event could be related to the manufacturing process of the unit.Therefore, no corrective or preventive actions will be taken at this time.

Event Description

As reported, the hub of a 5.2f straight pigtail 110cm 6 side hole (sh) super torque plus diagnostic catheter snapped off when a non-cordis high-pressure line was connected to it and actually cracked/broke.The plastic hub at proximal end of catheter snapped when being attached to the flush line.Catheter was removed without further incident.The procedure was completed by inserting a new unknown catheter and a non-cordis pressure tubing was also replaced although not damaged during initial incident.There was no reported patient injury.The case was a st-elevated myocardial infarction (stemi) and this occurred during an attempt to perform a left ventricular (lv) flush study.No obvious external fault identified with catheter prior to use.The device was stored and prepped as per the instructions for use (ifu).There was no resistance met while advancing the device nor excessive torqueing was required.There was no resistance met while withdrawing the device.The device will be returned for evaluation.Addendum: as per the product evaluation the unit was thoroughly inspected observing that the luer hub presents a separation condition.The separated piece was retuned inside the connector of the unknown flushing line.

• Brand Name: CATH F5.2+ PIG 110CM 6SH
• 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: 14961097
• MDR Text Key: 300829727
• Report Number: 9616099-2022-05793
• Device Sequence Number: 1
• Product Code: DQO
• UDI-Device Identifier: 10705032012553
• UDI-Public: (01)10705032012553(17)240731(10)18046150
• Combination Product (y/n): N
• Reporter Country Code: AS
• PMA/PMN Number: K862244
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date: 10/10/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/08/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 533533
• Device Catalogue Number: 533533
• Device Lot Number: 18046150
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 09/15/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/17/2021
• 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: A NEW UNKNOWN CATHETER; NON-CORDIS HIGH-PRESSURE LINE; NON-CORDIS PRESSURE TUBING
• Patient Sex: Female