MAUDE Adverse Event Report: CATH F6INF PIG 110CM 6SH; CATHETER, INTRAVASCULAR, DIAGNOSTIC

Model Number N/A

Device Problem Crack (1135)

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

Event Date 01/29/2021

Event Type  malfunction  

Manufacturer Narrative

A review of the manufacturing documentation associated with lot 17812829 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

When using a 6f 110cm 6 side holes (6sh) infiniti pigtail diagnostic catheter, it was found that there was a fracture in the middle section.Therefore, the device was replaced with another unknown angiographic catheter to complete the operation.There was no reported patient injury.Angiography found that the right coronary artery (rca) had more than 80% stenosis and needed a percutaneous coronary intervention (pci) treatment.The rca had moderate calcification, moderate tortuosity, and moderate angulation.The device was stored and prepped according to the instructions for use (ifu).The user was experienced with the device.The device was opened in the sterile field.The device was not resterilized.The device was inspected when removed from the package before it was used and no anomalies were noted when removed from the package.The device was not inserted through a stopcock instead of a hemostatic valve.There was no separation that had to be snared out.There was no resistance met while advancing the device or while advancing the device over the guidewire.There was no excessive torqueing required.The device did not previously kink or bend in the area that cracked.The device had a crack approximately 150cm from the distal end.The device will be returned for evaluation.

Manufacturer Narrative

Complaint conclusion: when using a 6f 110cm 6 side holes (6sh) infiniti pigtail diagnostic catheter, it was found that there was a fracture in the middle section.Therefore, the device was replaced with another unknown angiographic catheter to complete the operation.There was no reported patient injury.Angiography found that the right coronary artery (rca) had more than 80% stenosis and needed a percutaneous coronary intervention (pci) treatment.The rca had moderate calcification, moderate tortuosity, and moderate angulation.The device was stored and prepped according to the instructions for use (ifu).The user was experienced with the device.The device was opened in the sterile field.The device was not resterilized.The device was inspected when removed from the package before it was used and no anomalies were noted when removed from the package.The device was not inserted through a stopcock instead of a hemostatic valve.There was no separation that had to be snared out.There was no resistance met while advancing the device or while advancing the device over the guidewire.There was no excessive torquing required.The device did not previously kink or bend in the area that cracked.The device had a crack approximately 150cm from the distal end.The device was not returned for evaluation.The product was not returned for analysis.A product history record (phr) review of lot 17812829 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 for analysis and based on the information provided, the reported ¿catheter (body/shaft)- cracked¿ could not be confirmed and the exact root cause could not be determined.It is difficult to draw a clinical conclusion between the device and the events based on the information available.However, it is probable that handling factors such as the user¿s interaction with the device during device preparation may have contributed to the reported events.Per the instructions for use (ifu), although 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.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.¿ neither the phr review nor the information available suggests a design or manufacturing related cause could be related to the manufacturing process of the unit.Therefore, no corrective or preventive actions will be taken.

Manufacturer Narrative

Device was later received for analysis.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: when using a 6f 110cm 6 side holes (6sh) infiniti pigtail diagnostic catheter, it was found that there was a fracture in the middle section.Therefore, the device was replaced with another unknown angiographic catheter to complete the operation.There was no reported patient injury.Angiography found that the right coronary artery (rca) had more than 80% stenosis and needed a percutaneous coronary intervention (pci) treatment.The rca had moderate calcification, moderate tortuosity, and moderate angulation.The device was stored and prepped according to the instructions for use (ifu).The user was experienced with the device.The device was opened in the sterile field.The device was not resterilized.The device was inspected when removed from the package before it was used and no anomalies were noted when removed from the package.The device was not inserted through a stopcock instead of a hemostatic valve.There was no separation that had to be snared out.There was no resistance met while advancing the device or while advancing the device over the guidewire.There was no excessive torqueing required.The device did not previously kink or bend in the area that cracked.The device had a crack approximately 150cm from the distal end.A non-sterile unit of catheter (cath f6inf pig 110cm 6sh) was received for analysis.During the inspection a kinked condition on the body of the catheter was observed located at 33, 36, and 96 cm from the distal tip.No other damages or anomalies were observed on the returned device.Dimensional analysis was performed to verify the correct catheter inner diameter (id) and outer diameter (od) measurements were taken near to the damages.Dimensional analysis results were found within specification.The catheter was flushed prior to the verification.Functional analysis was performed.One 0.038¿ lab sample guidewire was inserted inside the catheter via distal tip.No anomalies were observed.A product history record (phr) review of lot 17812829 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 ¿catheter (body/shaft) - cracked¿ was not confirmed since this condition was not observed on the catheter body as returned.However, a kinked/bent condition was found on the body of the catheter.Procedural/handling factors or vessel characteristics (80% stenosis, moderate tortuosity and angulation) may have contributed to the reported event.Per the instructions for use (ifu), although 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.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.¿ neither the phr review nor the product analysis suggests that the reported failure could be related to the manufacturing process of the unit.No corrective or preventive actions will be taken.

• Brand Name: CATH F6INF PIG 110CM 6SH
• Type of Device: CATHETER, INTRAVASCULAR, DIAGNOSTIC
• MDR Report Key: 11364155
• MDR Text Key: 234378037
• Report Number: 9616099-2021-04287
• Device Sequence Number: 1
• Product Code: DQO
• UDI-Device Identifier: 20705032014394
• UDI-Public: 20705032014394
• Combination Product (y/n): N
• PMA/PMN Number: K970854
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 07/08/2021

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: 09/30/2021
• Device Model Number: N/A
• Device Catalogue Number: 534650S
• Device Lot Number: 17812829
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/03/2021
• Initial Date Manufacturer Received: 01/29/2021
• Initial Date FDA Received: 02/23/2021
• Supplement Dates Manufacturer Received: 03/02/2021; 06/03/2021; 07/02/2021
• Supplement Dates FDA Received: 03/03/2021; 06/24/2021; 07/08/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/04/2018
• 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
• Patient Age: 71 YR
• Patient Weight: 60