MAUDE Adverse Event Report: CORDIS US. CORP TEMPO; CATHETER, INTRAVASCULAR, DIAGNOSTIC

Catalog Number	451442V0
Medical Device Problem Code	Leak/Splash (1354)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/04/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
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.
Event or Problem Description
As reported, a 4f 65cm tempo cobra ¿ child 1 (c1) diagnostic catheter was drawing back air when connected to a mechanical contrast pump.As a result, a new 4f 65cm tempo cobra c1 diagnostic catheter was used as a replacement.There was no reported injury to the patient.The device was in the iliac artery when the draw back was being performed and the tip of the catheter was sitting freely within the vessel.There were no signs of calcification, stenosis, or tortuosity present in the target vessel.A non-cordis high pressure tubing was used.There was no difficulty connecting the tubing to the tempo catheter and no leakage was observed at either end of the high-pressure tubing.The malfunction occurred prior to taking an angiogram with the c1 catheter; however, one ¿pigtail run¿ was performed prior to the use of the c1 catheter.The device was stored and prepped per the instructions for use (ifu) and there was no difficulty flushing the device.The device will be returned for evaluation.
Additional Manufacturer Narrative
A review of the manufacturing documentation associated with lot 18174486 presented no issues during the manufacturing process that can be related to the reported event.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.
Additional Manufacturer Narrative
After further review of additional information received the following sections have been updated accordingly: b4, g3, g6, h1, h2, h3, h6, and h10.This device has been analyzed but the final, approved draft of the engineering report and its conclusion 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.H3 other text : this device has been analyzed but the final, approved draft of the engineering report and its conclusion is not yet available.However, it will be submitted within 30 days upon receipt.
Additional Manufacturer Narrative
Complaint conclusion: as reported, a 4f 65cm tempo cobra ¿ child 1 (c1) diagnostic catheter was drawing back air when connected to a mechanical contrast pump.As a result, a new 4f 65cm tempo cobra c1 diagnostic catheter was used as a replacement.There was no reported injury to the patient.The device was in the iliac artery when the draw back was being performed and the tip of the catheter was sitting freely within the vessel.There were no signs of calcification, stenosis, or tortuosity present in the target vessel.A non-cordis high pressure tubing was used.There was no difficulty connecting the tubing to the tempo catheter and no leakage was observed at either end of the high-pressure tubing.The malfunction occurred prior to taking an angiogram with the c1 catheter; however, one ¿pigtail run¿ was performed prior to the use of the c1 catheter.The device was stored and prepped per the instructions for use (ifu) and there was no difficulty flushing the device.One cath tempo 4f c1 65cm was received for evaluation.During visual inspection no anomalies were observed.Inner diameter (id) and outer diameter (od) measurements were taken and found within specification.A flushing test was performed, and no leakage was observed.Additionally, a portion of the catheter was clamped, and no leakage was observed during flushing.A product history record (phr) review of lot 18174486 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 as ¿catheter (body/shaft)-leakage¿ was not confirmed since no leaks were found during functional testing.Aspiration of air through the non-cordis extension tubing or the presence of preexisting air prior to aspiration are possible causes of the reported events.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, ¿store in a cool, dark, dry place.Do not use if package is open or damaged.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.¿ 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: TEMPO
• Common Device Name: CATHETER, INTRAVASCULAR, DIAGNOSTIC
• Manufacturer (Section D): CORDIS US. CORP; 14201 nw 60 avenue; miami lakes, florida 33014
• Manufacturer (Section G): CORDIS US CORP.; 14201 nw 60 avenue; miami lakes, florida 33014
• Manufacturer Contact: karla castro ; santiago troncoso 808; juarez, chihuahua ; 7863138372
• MDR Report Key: 17228380
• Report Number: 9616099-2023-06538
• Device Sequence Number: 6969775
• Product Code: DQO
• UDI-Device Identifier: 10705032008020
• UDI-Public: (01)10705032008020(17)251231(10)18174486
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K973401
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup,Followup
• Report Date (Section B): 10/18/2023

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 Catalogue Number: 451442V0
• Device Lot Number: 18174486
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/21/2023
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/06/2023
• Supplement Date Received by Manufacturer: 07/03/2023; 09/13/2023; 10/09/2023
• Initial Report FDA Received Date: 06/29/2023
• Supplement Report FDA Received Date: 07/28/2023; 10/09/2023; 10/18/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/07/2023
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown