MAUDE Adverse Event Report: CORDIS CORPORATION SI BRITE TIP 7F 45CM STR; INTRODUCER, CATHETER

Model Number 401745M

Device Problems Difficult to Remove (1528); Unraveled Material (1664)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 06/09/2022

Event Type  Injury  

Manufacturer Narrative

A review of the manufacturing documentation associated with lot 18072094 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.

Event Description

As reported, a 7f str brite tip catheter sheath introducer (csi) kinked in "the bifurcation massively".It was "heavy" to pull the devices out, with the handling the brite tip csi expanded near the kink.The material "got less" (color got more transparent) and became softer.The physician was afraid, that the sheath could tear off.He needed a lot of "material" to pull the sheath out.The way for this success was, to inflate a.018 saber balloon catheter in the near of the tip of the sheath and pull the balloon and the sheath together out of the patient.The patient was not harmed.There was no reported patient injury.The device was stored and prepped according to the instructions for use.The sheath was in place for 15 minutes.The sheath was not used for any infusions other than contrast media.The procedure was an endovascular treatment of stenosis of the left leg.The procedure used a crossover from the common femoral artery into the right external and common iliac artery, ending in the left common iliac artery ( which was covered with an old nitinol stent).The vessel was severely calcified, mildly tortuous, with mild stenosis and moderate bifurcation.The first treatment with standard material was not successful, therefore the physician decided to exchange for a poenix arteriotomy device.The device will be returned for evaluation.

Manufacturer Narrative

As reported, a 7f str brite tip catheter sheath introducer (csi) kinked in "the bifurcation massively".It was "heavy" to pull the devices out, with the handling the brite tip csi expanded near the kink.The material "got less" (color got more transparent) and became softer.The physician was afraid, that the sheath could tear off.He needed a lot of "material" to pull the sheath out.The way for this success was, to inflate a.018 saber balloon catheter in the near of the tip of the sheath and pull the balloon and the sheath together out of the patient.The patient was not harmed.There was no reported patient injury.The device was stored and prepped according to the instructions for use.The sheath was in place for 15 minutes.The sheath was not used for any infusions other than contrast media.The procedure was an endovascular treatment of stenosis of the left leg.The procedure used a crossover from the common femoral artery into the right external and common iliac artery, ending in the left common iliac artery (which was covered with an old nitinol stent).The vessel was severely calcified, mildly tortuous, with mild stenosis and moderate bifurcation.The first treatment with standard material was not successful, therefore the physician decided to exchange for a phoenix arteriotomy device.One image was received for analysis and a kinked/bent condition was noted.Dried blood was also noted on the csi.The product was not returned for analysis.A product history record (phr) review of lot 18072094 revealed no anomalies or non-conformances during the manufacturing and inspection processes that can be associated with the reported event.The reported malfunction, ¿catheter sheath introducer (csi)-kinked/bent-in patient¿ was confirmed based on the image review.Without the return of the device, the reported customer events ¿catheter sheath introducer (csi)-withdrawal difficulty¿ and ¿catheter sheath introducer (csi) unraveled/stretched-in patient¿ could not be confirmed.Patient specific vessel characteristics leading to entrapment of the device may be the cause 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, ¿if increased resistance is felt upon insertion of the csi, investigate the cause before continuing.If the cause of the resistance cannot be determined and corrected, discontinue the procedure and withdraw the csi.¿ 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.

Manufacturer Narrative

As reported, a 7f str brite tip catheter sheath introducer (csi) kinked in "the bifurcation massively".It was "heavy" to pull the devices out and the brite tip csi expanded near the kink.The material "got less" (color got more transparent) and became softer.The physician was afraid, the sheath could tear off.He needed a lot of "material" to pull the sheath out.He inflated an.018 saber balloon catheter near the tip of the sheath and pulled the balloon and the sheath out together.There was no reported patient injury.The device was stored and prepped according to the instructions for use.The sheath was in place for 15 minutes.The sheath was not used for any infusions other than contrast media.The procedure was an endovascular treatment of stenosis of the left leg.The procedure used a crossover from the common femoral artery into the right external and common iliac artery, ending in the left common iliac artery (which was covered with an old nitinol stent).The vessel was severely calcified, mildly tortuous, with mild stenosis and moderate bifurcation.The first treatment with standard material was not successful, therefore the physician decided to exchange for an arteriotomy device.One picture related to the reported failure was submitted for review.The picture shows a csi with a kinked/bent condition.Bloody residue could be observed.One non-sterile unit of si brite tip 7f 45cm str was received for analysis.The catheter sheath introducer and the vessel dilator were returned for analysis.During visual analysis, a kinked/bent and a compressed/crushed condition was found on the csi cannula located at 29 and 24.4 cm from distal tip.The length, inner diameter (id) and outer diameter (od) were measured near the damages and found out of specification.These findings suggest the cannula was elongated.Sem analysis was performed near the kink and where the measurements were taken to determine if the material presents signs of an elongated condition.Results provided evidence of fatigue striations.A product history record (phr) review of lot 18072094 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 ¿catheter sheath introducer (csi) - withdrawal difficulty¿ could not be confirmed because the event could not be properly evaluated due to the nature of the complaint.The complaints ¿catheter sheath introducer (csi) - kinked/bent - in patient¿ and ¿cannula - unraveled/stretched - in patient¿ were confirmed since the csi was found kinked/bent and compressed/crushed.Additionally, the device was found elongated (stretched).The fatigue striations found on the cannula are commonly associated with elongations caused by material tensile overload.Therefore, it is assumed that the cannula was induced to a tensile force that exceeded the material yield strength prior to the elongation.The exact cause of the damages could not be determined during analysis however, attempting to withdraw the device against resistance may have been the contributing factor.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, ¿remove the sheath when clinically indicated by placing compression on the vessel above the puncture site, and slowly withdraw the csi.¿ 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.

Event Description

As reported, a 7f str brite tip catheter sheath introducer (csi) kinked in "the bifurcation massively".It was "heavy" to pull the devices out, with the handling the brite tip csi expanded near the kink.The material "got less" (color got more transparent) and became softer.The physician was afraid, that the sheath could tear off.He needed a lot of "material" to pull the sheath out.The way for this success was, to inflate a.018 saber balloon catheter in the near of the tip of the sheath and pull the balloon and the sheath together out of the patient.The patient was not harmed.There was no reported patient injury.The device was stored and prepped according to the instructions for use.The sheath was in place for 15 minutes.The sheath was not used for any infusions other than contrast media.The procedure was an endovascular treatment of stenosis of the left leg.The procedure used a crossover from the common femoral artery into the the right external and common iliac artery, ending in the left common iliac artery ( which was covered with an old nitinol stent).The vessel was severely calcified, mildly tortuous, with mild stenosis and moderate bifurcation.The first treatment with standard material was not successful, therefore the physician decided to exchange for a poenix arteriotomy device.The device wasreturned 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.

• Brand Name: SI BRITE TIP 7F 45CM STR
• Type of Device: INTRODUCER, CATHETER
• Manufacturer (Section D): CORDIS CORPORATION; 14201 nw 60 avenue; miami lakes FL 33014
• Manufacturer (Section G): CORDIS CORPORATION; 14201 nw 60 avenue; miami lakes 33014
• Manufacturer Contact: karla castro ; 14201 nw 60 avenue; miami lakes, FL 33014 ; 7863138372
• MDR Report Key: 14959637
• MDR Text Key: 295526534
• Report Number: 9616099-2022-05791
• Device Sequence Number: 1
• Product Code: DYB
• UDI-Device Identifier: 20705032000335
• UDI-Public: (01)20705032000335(17)241130(10)18072094
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: K984500
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 11/04/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 401745M
• Device Catalogue Number: 401745M
• Device Lot Number: 18072094
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/16/2022
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 06/15/2022
• Initial Date FDA Received: 07/08/2022
• Supplement Dates Manufacturer Received: 07/15/2022; 09/07/2022; 10/21/2022
• Supplement Dates FDA Received: 07/23/2022; 10/03/2022; 11/04/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 02/03/2021
• 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: POENIX ARTERIOTOMY DEVICE; SABER .018 BALLOON
• Patient Age: 78 YR
• Patient Sex: Male
• Patient Weight: 102 KG