MAUDE Adverse Event Report: CORDIS CORPORATION 4F TEMPO AQUA .038" 125CM VERT; CATHETER, INTRAVASCULAR, DIAGNOSTIC

Model Number SRD6108

Device Problem Detachment of Device or Device Component (2907)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 06/29/2020

Event Type  malfunction  

Manufacturer Narrative

The device was returned but the engineering report is pending.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.

Event Description

As reported, the 4f 125cm.038¿ vertebral (vert) tempo aqua angiographic catheter came apart into 2 pieces as there was a lot of stress was put on it.The device was used in a heavily calcified superficial femoral artery (sfa) origin.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.

Manufacturer Narrative

Complaint conclusion: as reported, the 4f 125cm.038¿ vertebral (vert) tempo aqua angiographic catheter came apart into 2 pieces as there was a lot of stress was put on it.The device was used in a heavily calcified superficial femoral artery (sfa) origin.There was no reported patient injury.The device was properly stored and opened in sterile field.The device was used in the patient.One non-sterile unit of a tempo aqua catheter (4f tempo aqua.038" 125cm vert) was received for analysis.During the visual inspection, the device was returned with an unknown guidewire inserted and it was received with the body/shaft separated.No other damages or anomalies were observed.Per sem analysis, results showed that the separated area of the body/shaft of the 4f tempo aqua unit presented evidence of elongations.Plastic deformation resulting in cup and cone shape-like and tension marks were observed on braid wires.Also, ductile dimples were found on the separated braid wire surfaces.The elongations found on the body/shaft material, the ductile dimples, plastic deformations resulting in a cup and cone like shape, and tension marks, are commonly associated with separations caused by material tensile overload.Therefore, it is assumed that the body/shaft material was induced to a tensile force that exceeded the braid wire and body/shaft material yield strength prior to the separation.No other anomalies were observed during sem analysis.A product history record (phr) review of lot 17934171 revealed no anomalies or non-conformances during the manufacturing and inspection processes that can be associated with the reported event.The reported event by the customer as ¿catheter (body/shaft) ¿ separated¿ was confirmed since the device was received separated.The elongations found on the body/shaft material, the ductile dimples, plastic deformations resulting in a cup and cone like shape, and tension marks are commonly associated with separations caused by material tensile overload.Therefore, it is assumed that the body/shaft material was induced to a tensile force that exceeded the braid wire and body/shaft material yield strength prior to the separation.Procedural/handling factors and/or vessel characteristics (heavily calcified sfa) might have contributed to the reported conditions.Per the instructions for use (ifu), although not intended as a mitigation of risk, ¿exercise care when removing guidewires from multiple-curve catheters.To prevent kinking of 5f (1.65 mm) and smaller angiographic catheters: straighten the pigtail catheter tip only with a diagnostic guidewire or, if applicable, with a tip straightener.Do not straighten by hand.Use a guidewire when introducing the catheter through the catheter sheath introducer (csi) and into the left ventricle.The performance of these products may be impaired if not properly and cautiously handled during unpacking and preparation.Before use, flush all devices entering a blood vessel with sterile heparinized saline or a similar isotonic solution.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 phr review nor the product analysis suggests that the reported failure could be related to the manufacturing process of the unit.No corrective or preventive actions will be taken.

Manufacturer Narrative

H6 evaluation codes 1528- difficult to remove 3038- catheter additional information is pending and will be submitted within 30 days upon receipt.

Event Description

As reported, the 4f 125cm.038¿ vertebral (vert) tempo aqua angiographic catheter came apart into 2 pieces as there was a lot of stress was put on it.The device was used in a heavily calcified superficial femoral artery (sfa) origin.There was no reported patient injury.The device was properly stored and opened in sterile field.The device was used in patient.The device separated inside the patient.The device was prepped according to the instructions for use.The device was stored per ifu in the storeroom.There was moderate vessel tortuosity.There was little vessel angulation.The device was used for a chronic total occlusion (total occlusion >3 months).The device was not re-sterilized.Resistance was met while advancing the device.Excessive torquing was required.Resistance was not met while advancing the device over the guidewire.The device was kinked in the area of separation.Resistance was met while withdrawing the device.The product was not removed intact (in one piece) from the patient.The patient has since been discharged.

Manufacturer Narrative

Complaint conclusion: as reported, the 4f 125cm.038¿ vertebral (vert) tempo aqua angiographic catheter came apart into 2 pieces as there was a lot of stress was put on it.The device was used in a heavily calcified superficial femoral artery (sfa) origin.There was no reported patient injury.The device was properly stored and opened in sterile field.The device was used in patient.The device separated inside the patient.The device was prepped according to the instructions for use.The device was stored per ifu in the storeroom.There was moderate vessel tortuosity.There was little vessel angulation.The device was used for a chronic total occlusion (total occlusion >3 months).The device was not re-sterilized.Resistance was met while advancing the device.Excessive torquing was required.Resistance was not met while advancing the device over the guidewire.The device was kinked in the area of separation.Resistance was met while withdrawing the device.The product was not removed intact (in one piece) from the patient.The patient has since been discharged.One non-sterile unit of a tempo aqua catheter (4f tempo aqua.038" 125cm vert) was received for analysis.During the visual inspection, the device was returned with an unknown guidewire inserted and it was received with the body/shaft separated.No other damages or anomalies were observed.Dimensional analysis was performed to verify the correct catheter outer diameter (od).Measurements were taken at 4 distances from the distal tip.Dimensional analysis results were found within specification.Per sem analysis, results showed that the separated area of the body/shaft of the 4f tempo aqua unit presented evidence of elongations.Plastic deformation resulting in cup and cone-like shape and tension marks were observed on the braid wires.Also, ductile dimples were found on the separated braid wire surfaces.The elongations found on the body/shaft material, the ductile dimples, plastic deformations resulting in a cup and cone like shape, and tension marks, are commonly associated with separations caused by material tensile overload.Therefore, it is assumed that the body/shaft material was induced to a tensile force that exceeded the braid wire and body/shaft material yield strength prior to the separation.No other anomalies were observed during sem analysis.A product history record (phr) review of lot 17934171 revealed no anomalies or non-conformances during the manufacturing and inspection processes that can be associated with the reported event.The reported events by the customer as ¿catheter (body/shaft) ¿ tracking difficulty¿ and ¿catheter (body/shaft) ¿ withdrawal difficulty - from vessel¿ were not confirmed since the event reported cannot be properly evaluated due to the nature of the complaint, however, dimensional analysis was found within specification.The reported event by the customer as ¿catheter (body/shaft) ¿ separated¿ was confirmed since the device was received separated.The elongations found on the body/shaft material, the ductile dimples, plastic deformations resulting in a cup and cone like shape, and tension marks are commonly associated with separations caused by material tensile overload.Therefore, it is assumed that the body/shaft material was induced to a tensile force that exceeded the braid wire and body/shaft material yield strength prior to the separation.Procedural/handling factors and/or vessel characteristics (heavily calcified sfa, cto) might have contributed to the reported conditions.Per the instructions for use (ifu), although not intended as a mitigation of risk, ¿exercise care when removing guidewires from multiple-curve catheters.To prevent kinking of 5f (1.65 mm) and smaller angiographic catheters: straighten the pigtail catheter tip only with a diagnostic guidewire or, if applicable, with a tip straightener.Do not straighten by hand.Use a guidewire when introducing the catheter through the catheter sheath introducer (csi) and into the left ventricle.The performance of these products may be impaired if not properly and cautiously handled during unpacking and preparation.Before use, flush all devices entering a blood vessel with sterile heparinized saline or a similar isotonic solution.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 phr review nor the product analysis suggests that the reported failure could be related to the manufacturing process of the unit.No corrective or preventive actions will be taken.

• Brand Name: 4F TEMPO AQUA .038" 125CM VERT
• Type of Device: CATHETER, INTRAVASCULAR, DIAGNOSTIC
• Manufacturer (Section D): CORDIS CORPORATION; 14201 nw 60 avenue; miami lakes FL 33014
• MDR Report Key: 10322768
• MDR Text Key: 200381809
• Report Number: 9616099-2020-03802
• Device Sequence Number: 1
• Product Code: DQO
• UDI-Device Identifier: 20705032049785
• UDI-Public: 20705032049785
• Combination Product (y/n): N
• PMA/PMN Number: K000579
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 09/15/2020

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: 01/31/2023
• Device Model Number: SRD6108
• Device Catalogue Number: SRD6108
• Device Lot Number: 17934171
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/14/2020
• Initial Date Manufacturer Received: 06/29/2020
• Initial Date FDA Received: 07/24/2020
• Supplement Dates Manufacturer Received: 08/07/2020; 07/27/2020; 09/02/2020
• Supplement Dates FDA Received: 08/14/2020; 08/26/2020; 09/15/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1