MAUDE Adverse Event Report: CORDIS CORPORATION CATH TEMPO 4F UF 65CM 5SH; CATHETER, INTRAVASCULAR, DIAGNOSTIC

Model Number 451404V5

Device Problem Material Puncture/Hole (1504)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 07/21/2020

Event Type  malfunction  

Manufacturer Narrative

As reported, the tempo 4f uf 65cm 5sh catheter was taken up to the iliac arch.The aquatrack appeared to exit through the side hole of the tempo 4f uf 65cm 5sh and not the end hole.Therefore, the tempo angiographic catheter was replaced with another unknown uf catheter and the procedure was completed.The catheter was stored on a shelf with the other catheters for approximately one month.The device was stored, handled and prepped according to the instructions for use (ifu).There was no difficulty experienced in prepping the device.There were no anomalies noted to the device when they were taken out of the packaging.There were no difficulties removing the product from the packaging.The catheter did not kink or bend at any time prior to the resistance/friction.There was unusual force used during the procedure.The target lesion was the iliac with moderate calcification.There was moderate vessel tortuosity.There was seventy percent stenosis.The device was not used for a chronic total occlusion.There was no reported patient injury.The device was properly stored and opened in sterile field.The device was used in patient.One non-sterile unit of a tempo catheter (cath tempo 4f uf 65cm 5sh) was received for analysis.During the visual inspection, no damages or anomalies were observed.Per functional analysis, a flushing test was performed in order to find a possible puncture/cut.The test was performed with no difficulties and no anomalies were found.A product history record (phr) review of lot 17927529 revealed no anomalies or non-conformance's during the manufacturing and inspection processes that can be associated with the reported event.The reported ¿catheter (body/shaft) puncture/cut¿ was not confirmed since no puncture/cut was noted during visual inspection nor the flushing test.Procedural and/or handling factors might have contributed to the reported event.Per the ifu, which is not intended as a mitigation of risk, the performance of these products may be impaired if not properly and cautiously handled during unpacking and preparation.For all catheters: 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.Exercise care when removing guidewires from multiple-curve catheters.Procedures requiring percutaneous catheter introduction should not be attempted by physicians unfamiliar with the possible complications.Complications may occur at any time during or after the procedure.¿ neither the product analysis nor the information available suggests that the failure experienced by the customer could be related to the manufacturing process.Therefore, no actions will be taken at this time.

Event Description

As reported, the tempo 4f uf 65cm 5sh catheter was taken up to the iliac arch.The aquatrack appeared to exit through the side hole of the tempo 4f uf 65cm 5sh and not the end hole.Therefore, the tempo angiographic catheter was replaced with another unknown uf catheter and the procedure was completed.The catheter was stored on a shelf with the other catheters for approximately one month.The device was stored, handled and prepped according to the instructions for use (ifu).There was no difficulty experienced in prepping the device.There were no anomalies noted to the device when they were taken out of the packaging.There were no difficulties removing the product from the packaging.The catheter did not kink or bend at any time prior to the resistance/friction.There was unusual force used during the procedure.The target lesion was the iliac with moderate calcification.There was moderate vessel tortuosity.There was seventy percent stenosis.The device was not used for a chronic total occlusion.There was no reported patient injury.The device was properly stored and opened in sterile field.The device was used in patient.The device will be returned for evaluation.

• Brand Name: CATH TEMPO 4F UF 65CM 5SH
• Type of Device: CATHETER, INTRAVASCULAR, DIAGNOSTIC
• Manufacturer (Section D): CORDIS CORPORATION; 14201 nw 60th ave; miami lakes FL 33014
• Manufacturer (Section G): CORDIS CORPORATION; 14201 nw 60th ave; miami lakes FL 33014
• Manufacturer Contact: karla castro ; 14201 nw 60th ave; miami lakes, FL 33014 ; 7863138372
• MDR Report Key: 10468378
• MDR Text Key: 206315419
• Report Number: 9616099-2020-03873
• Device Sequence Number: 1
• Product Code: DQO
• UDI-Device Identifier: 10705032007733
• UDI-Public: 10705032007733
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K973401
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 08/28/2020

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: 12/31/2022
• Device Model Number: 451404V5
• Device Catalogue Number: 451404V5
• Device Lot Number: 17927529
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/04/2020
• Initial Date Manufacturer Received: 07/31/2020
• Initial Date FDA Received: 08/28/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/31/2020
• 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