MAUDE Adverse Event Report: CORDIS CORPORATION CATH TEMPO 5F PIG 100CM 5SH; CATHETER, INTRAVASCULAR, DIAGNOSTIC

Model Number N/A

Device Problem Difficult to Remove (1528)

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

Event Date 03/14/2022

Event Type  malfunction  

Manufacturer Narrative

The device was not returned for analysis.A device history record review was performed and showed that these lots of products met all requirements per the applicable manufacturing quality plan.Additional information is pending and will be submitted within 30 days upon receipt.This is one of two reports associated with the reported event and the related report number will be provided upon submission of the report.

Event Description

During a left common carotid artery angiography using 2 5f pig 100cm tempo simon catheters, one of the catheters bent in the iliac artery.A non-cordis guide wire could not be passed and the removal of the catheter was difficult.The surgeon said that the tip of the cordis angiography tube was soft, the catheter was broken during the insertion process, it was difficult to retract from the blood vessel wall and the patient suffered from a spasm.With the help of the guidewire, the surgeon slowly adjusted the angle so that the folded tip was slowly straightened until it could be withdrawn from the body smoothly.After it was replaced, the angiographic catheter bent again.The second cordis angiography tube still had a similar situation to the first one.The surgeon took longer to deal with the bent and retraction of the catheter, and the patient experienced spasm during the procedure, and the procedure was finally completed.The patient underwent a cerebral angiography under local anesthesia.The patient had a type ii aortic arch,.The access site was the femoral artery.There was no difficulty prepping the device.There was no difficulty prepping the devices.The left common carotid artery to the brachiocephalic trunk and the right iliac artery were curved.The devices will not be returned.The hospital reported it as an adverse event to the (b)(6) directly.Patient information was not available.

Manufacturer Narrative

The spasms were not treated and resolved when the catheters were removed.This report is related to the events reported under manufacturing report number 9616099-2022-05615.

Manufacturer Narrative

During a left common carotid artery angiography using 2 5f pig 100cm tempo simon catheters, one of the catheters bent in the iliac artery.A non-cordis guide wire could not be passed and the removal of the catheter was difficult.The surgeon said that the tip of the cordis angiography tube was soft, the catheter was broken during the insertion process, it was difficult to retract from the blood vessel wall and the patient suffered from a spasm.With the help of the guidewire, the surgeon slowly adjusted the angle so that the folded tip was slowly straightened until it could be withdrawn from the body smoothly.After it was replaced, the angiographic catheter bent again.The second cordis angiography tube still had a similar situation to the first one.The surgeon took longer to deal with the bent and retraction of the catheter, and the patient experienced spasm during the procedure, and the procedure was finally completed.The spasms were not treated and resolved when the catheters were removed.The patient underwent a cerebral angiography under local anesthesia.The patient had a type ii aortic arch,.The access site was the femoral artery.There was no difficulty prepping the device.There was no difficulty prepping the devices.The left common carotid artery to the brachiocephalic trunk and the right iliac artery were curved.The products were not returned for analysis however, it was reported both affected devices share the same lot number.A product history record (phr) review of lot 18026546 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 events ¿brite tip/distal tip - catheters- kinked/bent - in-patient¿ and ¿catheter (body/shaft)- withdrawal difficulty - from vessel¿ could not be confirmed.Vessel characteristics and/or handling factors such as excessive catheter manipulation may have contributed to the reported event.Arterial spasm is a known potential adverse event associated with any interventional procedure where devices are introduced into the vasculature and can be caused by the device manipulations inherent in any procedure causing endothelial irritation.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, ¿complications may occur at any time during or after the procedure.Possible complications include but are not limited to the following: air embolism, hematoma at the puncture site, infection, and perforation of the vessel wall.¿ 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: CATH TEMPO 5F PIG 100CM 5SH
• Type of Device: CATHETER, INTRAVASCULAR, DIAGNOSTIC
• Manufacturer (Section D): CORDIS CORPORATION; 14201 nw 60 avenue; miami lakes FL 33014
• Manufacturer (Section G): CORDIS CORPORATION; cordis corporation; miami lakes FL 33014
• Manufacturer Contact: karla castro ; 14201 nw 60 avenue; miami lakes, FL 33014 ; 7863138372
• MDR Report Key: 14337947
• MDR Text Key: 292843470
• Report Number: 9616099-2022-05608
• Device Sequence Number: 1
• Product Code: DQO
• UDI-Device Identifier: 10705032003273
• UDI-Public: (01)10705032003273(17)240430(10)18026546
• Combination Product (y/n): N
• Reporter Country Code: CH
• PMA/PMN Number: K973401
• 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: 05/25/2022

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: 04/30/2024
• Device Model Number: N/A
• Device Catalogue Number: 451503H5
• Device Lot Number: 18026546
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 04/11/2022
• Initial Date FDA Received: 05/09/2022
• Supplement Dates Manufacturer Received: 05/06/2022; 05/03/2022
• Supplement Dates FDA Received: 05/10/2022; 05/25/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/28/2021
• 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
• Patient Sex: Prefer Not To Disclose