MAUDE Adverse Event Report: CORDIS CORPORATION CATH MB 5F PIG 65CM 8SH; CATHETER, INTRAVASCULAR, DIAGNOSTIC

Model Number 532598C

Device Problem Detachment of Device or Device Component (2907)

Patient Problem Foreign Body In Patient (2687)

Event Date 09/07/2021

Event Type  Injury  

Manufacturer Narrative

A review of the manufacturing documentation associated with lot 18027230 presented no issues during the manufacturing process that can be related to the reported event.Pictures are 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 Description

As reported, a cath mb 5f pig 65cm 8sh broke in the sheath during withdrawal from the vessel.The catheter shaft separated into two separate pieces.A second wire was inserted into the sheath and a balloon was inserted into the sheath.The balloon was inflated, thus securing the broken catheter.Everything was then pulled out together.The procedure was completed by placed a non cordis aaa limb in the external iliac artery.There was no reported patient injury.The event did not cause a clinically relevant increase in the duration of the procedure.The event did not cause a condition that requires hospitalization or significant prolongation of existing hospitalization.The reported event caused no patient injury or deterioration in health.The intended procedure was an endovascular repair (evar) and the catheter was being used to measure the length of the common iliac artery.There was moderate calcification, mild tortuosity, mild angulation, 20% stenosis, and it was not a cto.The device was not resterilized.There were no anomalies noted when removed from the package nor during prep.The device was stored and prepped as per the instructions for use (ifu).A 14f non cordis sheath was used.A 0.035" non cordis guidewire was used.There was no resistance when advancing the device.There was no kink in the area of separation.There was no resistance while withdrawing the device.There was no difficulty tracking through the vasculature.The device is expected to be returned for evaluation.

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.Pictures have 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.

Manufacturer Narrative

Complaint conclusion: as reported, a cath mb 5f pig 65cm 8sh broke in the sheath during withdrawal from the vessel.The catheter shaft separated into two separate pieces.A second wire and a balloon were inserted into the sheath.The balloon was inflated, thus securing the broken catheter.Everything was then pulled out together.The procedure was completed after placing a non-cordis aaa limb in the external iliac artery.There was no reported patient injury.The event did not cause a clinically relevant increase in the duration of the procedure.The event did not cause a condition that requires hospitalization or significant prolongation of existing hospitalization.The intended procedure was an endovascular repair (evar), and the catheter was being used to measure the length of the common iliac artery.There was moderate calcification, mild tortuosity, mild angulation, 20% stenosis, and it was not a cto.The device was not resterilized.There were no anomalies noted when removed from the package nor during prep.The device was stored and prepped as per the instructions for use (ifu).A 14f non-cordis sheath and a non-cordis 0.035 guidewire was used.There was no resistance when advancing the device, no kink in the area of the separation, no resistance while withdrawing the device and no difficulty tracking through the vasculature.One picture was received for analysis.Per visual analysis, the body/shaft of the unit was observed separated and the unit was covered with bloody residue.Additionally, several marker bands were observed offset/out of position.One non-sterile cath mb 5f pig 65cm 8sh unit was received for analysis.Six of the twenty marker bands were noted to be offset/out of position at the proximal section of the unit.A separated condition approximately 37.5 cm from distal tip was also noted.No other anomalies were observed during the visual analysis.Inner diameter (id) and outer diameter (od) measurements were taken near the damages and were found within specification.Functional analysis could not be performed due the separated condition of the unit.Amplified images of the moved marker bands were taken via microscopic analysis and no anomalies were observed.Sem analysis presented evidence of elongations and a flared condition on the body/shaft material of the unit.No other anomalies were observed.A product history record (phr) review of lot 18027230 revealed no anomalies or non-conformances during the manufacturing and inspection processes that can be associated with the reported event.The event reported by the customer, ¿catheter (body/shaft) ¿ separated - in-patient¿ was confirmed since a separation was noted.The elongations found on the body/shaft material of the unit are commonly associated with separations caused by material tensile overload.Therefore, it is assumed the body/shaft material was induced to a tensile force that exceeded the body/shaft material yield strength prior to the separation.Procedural/handling factors such as entrapment of the catheter between other endovascular devices and the vessel wall may have contributed to this issue.Although not intended as a mitigation of risk, 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), ¿manipulation of the catheter under excessive friction due to interaction with other devices or while trapped in the vasculature, can lead to stretching or elongation of the catheter.Stretching or elongation of the catheter during endovascular procedures could result in the marker bands moving along the catheter.In extreme cases, marker bands may come off the catheter and dislodge into the vascular system.Avoid entrapment of the catheter between other endovascular devices and the vessel wall.¿ based on the information available, product analysis, 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 MB 5F PIG 65CM 8SH
• Type of Device: CATHETER, INTRAVASCULAR, DIAGNOSTIC
• Manufacturer (Section D): CORDIS CORPORATION; 14201 nw 60 avenue; miami lakes FL 33014
• Manufacturer (Section G): CORDIS CORPORATION; 14201 nw 60 avenue; miami lakes FL 33014
• Manufacturer Contact: karla castro ; 14201 nw 60 avenue; miami lakes, FL 33014 ; 7863138372
• MDR Report Key: 12574913
• MDR Text Key: 274919079
• Report Number: 9616099-2021-04909
• Device Sequence Number: 1
• Product Code: DQO
• UDI-Device Identifier: 10705032012041
• UDI-Public: (01)10705032012041(17)240430(10)18027230
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: K915836
• 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: 11/09/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/05/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 04/30/2024
• Device Model Number: 532598C
• Device Catalogue Number: 532598C
• Device Lot Number: 18027230
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/08/2021
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/04/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/01/2021
• 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
• Treatment: COOK 14F SHEATH; COOK/LUNDAQUIST 0.035" WIRE; UNKNOWN BALLOON
• Patient Outcome(s): Life Threatening; Required Intervention
• Patient Age: 84 YR
• Patient Sex: Male
• Patient Weight: 48 KG