MAUDE Adverse Event Report: CORDIS CORPORATION SI AVANTI+ 8F STD W/GW NO OBT; DILATOR, VESSEL, FOR PERCUTANEOUS CATHETERIZATION

Model Number 504608X

Device Problems Partial Blockage (1065); Disconnection (1171); Material Separation (1562); Obstruction of Flow (2423); Detachment of Device or Device Component (2907)

Patient Problem Insufficient Information (4580)

Event Date 11/17/2021

Event Type  Injury  

Manufacturer Narrative

Additional information is pending and will be submitted within 30 days upon receipt.

Event Description

As reported, the avanti plus catheter sheath introducer (si avanti+ 8f std w/gw no obt) fell off (separated) from a patient and there was blood return.The patient's heart rate and blood pressure did not change at that time and small clips were used to clip the arterial collaterals and reflex the catheter to prevent bleeding.The patient was reported to have been initially admitted due to acute coronary syndrome and was placed in an intra-aortic balloon pump (iabp).The pump was subsequently replaced with a fixed catheter (the avanti plus catheter) which was found disconnected from the patient at bedtime.The collateral catheter was immediately reversed, and the event was reported to the doctor and head nurse.According to the additional information provided, the patient was reported to have been hospitalized due to acute myocardial infarction and acute thromboembolism and underwent a percutaneous coronary intervention (pci) via the anterior descending branch.The lesion was not calcified; there was no vessel tortuosity and ninety-percent stenosis.There were no anomalies noted when the product was removed from the package.The product was stored and handled according to the instructions for use (ifu).The product was inspected and prepped according to the ifu and there was no difficulty experienced when prepping the device.The patient did not require extended hospitalization as a result of this event.There was resistance during withdrawal of the sheath from the vessel.The physician removed the sheath and checked the inner diameter of the sheath to confirm if it was the same throughout the entire sheath, but there was a bulge (obstruction) which was believed to be the cause of the resistance.The reported separation occurred during procedural use.The product was discarded at site.

Manufacturer Narrative

As reported, the avanti plus catheter sheath introducer (si avanti+ 8f std w/gw no obt) fell off (separated) from a patient and there was blood return.The patient's heart rate and blood pressure did not change at that time and small clips were used to clip the arterial collaterals and reflex the catheter to prevent bleeding.The patient was reported to have been initially admitted due to acute coronary syndrome and was placed in an intra-aortic balloon pump (iabp).The pump was subsequently replaced with a fixed catheter (the avanti plus catheter) which was found disconnected from the patient at bedtime.The collateral catheter was immediately reversed, and the event was reported to the doctor and head nurse.According to the additional information provided, the patient was reported to have been hospitalized due to acute myocardial infarction and acute thromboembolism and underwent a percutaneous coronary intervention (pci) via the anterior descending branch.The lesion was not calcified; there was no vessel tortuosity and ninety-percent stenosis.There were no anomalies noted when the product was removed from the package.The product was stored and handled according to the instructions for use (ifu).The product was inspected and prepped according to the ifu and there was no difficulty experienced when prepping the device.The patient did not require extended hospitalization because of this event.There was resistance during withdrawal of the sheath from the vessel.The physician removed the sheath and checked the inner diameter of the sheath to confirm if it was the same throughout the entire sheath, but there was a bulge (obstruction) which was believed to be the cause of the resistance.The reported separation occurred during procedural use.The product was not returned for analysis as it was discarded.A product history record (phr) review of lot 18035168 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 sheath introducer- separated - in patient¿ and ¿catheter sheath introducer - obstructed - in patient¿ could not be confirmed.Procedural/handling factors 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, ¿aspirate from the sideport extension to remove any potential air.After aspiration and flushing, consider establishing a heparinized solution or suitable isotonic solution via the sideport extension.The addition of a heparinized saline drip via the sideport can help in the prevention of thrombus formation.Hold the sheath in place when inserting, positioning, or removing the catheter.The suture collar may be used as a temporary suture site.¿ 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.

• Brand Name: SI AVANTI+ 8F STD W/GW NO OBT
• Type of Device: DILATOR, VESSEL, FOR PERCUTANEOUS CATHETERIZATION
• Manufacturer (Section D): CORDIS CORPORATION; 14201 nw 60th avenue; miami lakes FL 33014 2802
• Manufacturer (Section G): CORDIS CORPORATION; 14201 nw 60th avenue; miami lakes FL 33014 2802
• Manufacturer Contact: karla castro ; 14201 nw 60th avenue; miami lakes, FL 33014-2802 ; 7863138372
• MDR Report Key: 13758832
• MDR Text Key: 290083725
• Report Number: 9616099-2022-05448
• Device Sequence Number: 1
• Product Code: DRE
• UDI-Device Identifier: 10705032010153
• UDI-Public: 10705032010153
• Combination Product (y/n): N
• Reporter Country Code: CH
• PMA/PMN Number: K970392
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Company Representative
• Reporter Occupation: Other
• Type of Report: Followup
• Report Date: 03/21/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/14/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 504608X
• Device Catalogue Number: 504608X
• Device Lot Number: 18035168
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 03/12/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/03/2021
• 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: UNK CATHETER
• Patient Outcome(s): Life Threatening