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

Catalog Number	451514H0
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/17/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The device is available for analysis but has not yet been received.Additional information is pending and will be submitted within 30 days upon receipt.
Event or Problem Description
As reported, a tempo 5 vertebral (vert) guidewire broke, as the catheter was externally withdrawn for left internal carotid angiography and two thirds of the catheter remained in the aorta.An unknown 10f vascular sheath was inserted in the right inguinal region, and an unknown 6f vascular sheath was inserted under local anesthesia in the left groin by puncturing the left aorta.The use of an unknown stiff guidewire, a pigtail catheter, and a non-cordis catheter was ineffective in pulling down the catheter.The distal end of the catheter was captured by introducing a recovery catheter and a gooseneck catcher through the right vascular sheath and pulled into the recovery catheter.After successful capture, the catheter and catcher were withdrawn and vascularized.If the catheter had not been removed in time, the patient might have needed to be transferred to the hospital for surgical removal, which would have prolonged the patient's recovery time and raise the risk of complications such as arterial dissection.The patient had undergone cerebral angiography in the catheterization laboratory due to cerebral stenosis.The patient had significant vascular tortuosity and severe stenosis of the basilar artery.The hospital reported it as an adverse event to the china nmpa directly.Please upgrade this case to ae.
Additional Manufacturer Narrative
The device was received for analysis, but the engineering report is not yet available.Additional information is pending and will be submitted within 30 days upon receipt.
Additional Manufacturer Narrative
As reported, the body shaft of a tempo 5 vertebral (vert) guidewire broke (separated), as the catheter was externally withdrawn from the left internal carotid angiography and two thirds of the catheter remained in the aorta.Another unknown catheter was used to complete the procedure.An unknown 10f vascular sheath was inserted in the right inguinal region, and an unknown 6f vascular sheath was inserted under local anesthesia in the left groin by puncturing the left aorta.The use of an unknown stiff guidewire, a pigtail catheter, and a non-cordis catheter was ineffective in pulling down the catheter.The distal end of the catheter was captured by introducing a recovery catheter and a gooseneck catcher through the right vascular sheath and pulled into the recovery catheter.After successful capture, the catheter and catcher were withdrawn and vascularized.If the catheter had not been removed in time, the patient might have needed to be transferred to the hospital for surgical removal, which would have prolonged the patient's recovery time and raise the risk of complications such as arterial dissection.The patient had undergone cerebral angiography in the catheterization laboratory due to cerebral stenosis.The patient had significant vascular tortuosity and severe stenosis of the basilar artery.The cerebrovascular lesion was calcified.There were no anomalies noted when the product was removed from the package.The product was stored, handled, inspected, and prepped according to the instructions for use (ifu).There was no difficulty experienced in prepping the device.There was no resistance/friction experienced during any part of the procedure nor resistance met while advancing the device.There was no excessive torquing required.The tip was visible on fluoroscopy throughout the procedure.The device was not re-sterilized.A unit of ¿cath tempo 5f ver 135° 100cm¿ was received for analysis.During visual inspection, the body/shaft was found separated from the proximal portion of the unit.Outer diameter (od) measurements were taken near the damages and were found within specification.Sem analysis presented evidence of complete body section separation where material elongation patterns and evidence of scratch marks were observed across the separation border.The reported ¿catheter (body/shaft) - separated¿ was confirmed since this condition was present on the device.The material elongation patterns, and evidence of scratch marks are commonly caused by an exposure to an excessive tensile force and/or interaction with sharp edges.Procedural/handling factors, which led to the application of excessive force, 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, ¿store in a cool, dark, dry place.Do not use if package is open or damaged.Multiple-curve catheters.To prevent kinking of 5f (1.65 mm) and smaller angiographic catheters, and specifically the 4f (1.35 mm) infiniti® pigtail catheters: 1.Straighten the pigtail catheter tip only with a diagnostic guidewire or, if applicable, with a tip straightener.Do not straighten by hand.2.Use a guidewire when introducing the catheter through the catheter sheath introducer (csi) and into the left ventricle¿ based on the available information, there is no indication that the event is related to the device design or manufacturing process.Therefore, no preventive or corrective actions will be taken at this time.
Additional Manufacturer Narrative
After further review, section d.4 primary unique device identification (udi) number has been corrected accordingly.

• Brand Name: TEMPO
• Common Device Name: CATHETER, INTRAVASCULAR, DIAGNOSTIC
• Manufacturer (Section D): CORDIS US CORP.; 14201 nw 60th avenue; miami lakes, florida 33014
• Manufacturer (Section G): CORDIS US CORP.; 14201 nw 60th avenue; miami lakes, florida 33014
• Manufacturer Contact: karla castro ; santiago troncoso 808; juarez, chihuahua ; 7863138372
• MDR Report Key: 18245560
• Report Number: 9616099-2023-06649
• Device Sequence Number: 7116233
• Product Code: DQO
• UDI-Device Identifier: 10705032008464
• UDI-Public: (01)10705032008464(17)250331(10)18105223
• 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): 08/14/2024

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
• Operator of Device: Health Professional
• Device Expiration Date: 03/31/2025
• Device Catalogue Number: 451514H0
• Device Lot Number: 18105223
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• 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: 11/07/2023
• Supplement Date Received by Manufacturer: 12/08/2023; 03/06/2024; 08/14/2024
• Initial Report FDA Received Date: 12/01/2023
• Supplement Report FDA Received Date: 12/08/2023; 03/08/2024; 08/14/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 04/25/2022
• 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
• Concomitant Medical Products and Therapy/Usage Dates: UNK 10F VASCULAR SHEATH; UNK 6F VASCULAR SHEATH; UNK GOOSENECK CATCHER; UNK GUIDEWIRE; UNK PIGTAIL CATHETER
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown