MAUDE Adverse Event Report: CARDINAL HEALTH MEXICO 244 S DE RL DE CV 10X40MM PRECISE PRO RX US CAROTID SYST; STENT, CAROTID

Model Number N/A

Device Problem Detachment of Device or Device Component (2907)

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

Event Date 10/18/2021

Event Type  malfunction  

Event Description

During an interventional procedure, there was difficulty encountered while advancing/tracking a 10x40 precise pro rx stent sds towards the lesion.It was delivered to the lesion but "when the stent was released , there was strong resistance.Therefore, it was replaced with a new precise (9mmx40mm) and it could be implanted without resistance and issue.Analysis of the returned device indicated partial stent deployment.The bifurcation angle from the common carotid artery to the internal carotid artery was tight." there was no reported patient injury.The intended procedure was a carotid artery stenting.The target lesion was the internal carotid artery (ica) to common carotid artery (cca).The target lesion vessel diameter was 6mm in the ica and 8mm in the cca.The target lesion vessel length was little less than 3 cm.There was almost no calcification and vessel tortuosity.The temperature exposure indicator on the pouch was checked to confirm that the black dotted pattern with a grey background is clearly visible.The product was stored, handled, inspected and prepped according to the instructions for use.There was nothing unusual noted about the stent delivery system prior to use.A 6f non-cordis sheath introducer was used with a 6f guiding catheter.Delivery of the sds to the lesion was ipsilateral.The stent delivery system did not pass through any acute bends.The user maintained a fixed inner shaft position during deployment.The stent did not prematurely deploy.The procedure was successfully completed by using a new precise.There was no patient information.The device will be returned for analysis.

Manufacturer Narrative

Please note that patient's exact age was not given but he is in his 70s.Concomitant devices continued: 6f guiding catheter.(b)(6).A non-sterile unit of ¿precise pro rx us carotid syst¿ was received for analysis coiled inside of a clear plastic bag.The device was unpacked and was placed at one metallic tray to be inspected.A thorough inspection was performed observing that the unit presents a partial stent deployment condition.The proximal stainless steel hypotube presents a kinked/bent condition. a kinked bent condition was observed the outer sheath located approximately at 7.5 cm from the distal tip.Also, a frayed condition on the outer sheath was noticed located approximately at 37 and 120 cm from the distal tip.The hemostasis valve was returned closed tight.No other damages or anomalies were observed.Tool.A review of the manufacturing documentation associated with the lot # 18014006 (b)(4) was performed and the phr review does not suggest that the failure experienced by the customer could be related to the manufacturing process.Before the deployment process the unit was flushed.Functional analysis was performed according to procedure to determine if the stent can be deployed as expected.Before the deployment process the unit was flushed.The hemostasis valve was unlocked of the stent delivery system.The stent deployment functionally test was initiate by retracting the outer sheath while holding the inner shaft in a fixed position.The push rod traveled toward the distal end deploying completely the stent as expected.  the stent expanded presenting no anomalies or damages.The failure reported by the customer as ¿stent delivery system (sds)-ses ~ deployment difficulty - unable ¿ was not confirmed.The functional test was performed successfully and the stent was deployed as expected.  the failure reported by the customer as ¿stent delivery system (sds)-ses ~ deployment difficulty - premature deployment¿ was confirmed, the unit was returned partially deployed.Additional information including additional testing of the device and will be submitted within 30 days upon receipt.

Manufacturer Narrative

Additional analysis: ftir results: the results obtained to determine the substance present on the surface of the catheter with catalog number pc1040rxc and lot 18014006, are presented below: two infrared spectra were taken from the ¿smooth section¿ as reference (black and red color line), two more were taken from the rough sections (blue and pink line) one of less wear and another where it presented more wear.Therefore, according to the first image, it can be seen that the bands present in the different sections of the material are similar, which means that the rough areas present in the catheter are typical of the outer body, moreover, no contaminant was found outside the composition of the catheter itself.Additional information is pending and will be submitted within 30 days upon receipt.

Manufacturer Narrative

Complaint conclusion: during an interventional procedure, there was difficulty encountered while advancing/tracking a 10x40 precise pro rx stent sds towards the lesion.It was delivered to the lesion but "when the stent was released, there was strong resistance.Therefore, it was replaced with a new precise (9mmx40mm) and it could be implanted without resistance and issue.The bifurcation angle from the common carotid artery to the internal carotid artery was tight." analysis of the returned device indicated partial stent deployment.The intended procedure was a carotid artery stenting.The target lesion was the internal carotid artery (ica) to common carotid artery (cca).The target lesion vessel diameter was 6mm in the ica and 8mm in the cca.The target lesion vessel length was little less than 3 cm.There was almost no calcification and vessel tortuosity.The temperature exposure indicator on the pouch was checked to confirm that the black dotted pattern with a grey background is clearly visible.The product was stored, handled, inspected, and prepped according to the instructions for use.There was nothing unusual noted about the stent delivery system prior to use.A 6f non-cordis sheath introducer was used with a 6f guiding catheter.Delivery of the sds to the lesion was ipsilateral.The stent delivery system did not pass through any acute bends.The user maintained a fixed inner shaft position during deployment.The stent did not prematurely deploy.The procedure was successfully completed by using a new precise.There was no reported patient injury.The device was returned for analysis.A non-sterile unit of ¿precise pro rx us carotid syst¿ was received for analysis coiled inside of a clear plastic bag.The device was unpacked and was placed at one metallic tray to be inspected.A thorough inspection was performed observing that the unit presents a partial stent deployment condition.The proximal stainless steel hypotube presents a kinked/bent condition.A kinked bent condition was observed on the outer sheath located approximately at 7.5 cm from the distal tip.Also, at 37 and 120 cm from the distal tip the outer sheath presented residuals.The hemostasis valve was returned closed tight.No other damages or anomalies were observed.Functional analysis was performed to determine if the stent can be deployed as expected.Before the deployment process the unit was flushed.The hemostasis valve was unlocked of the stent delivery system.The stent deployment functionally test was initiate by retracting the outer sheath while holding the inner shaft in a fixed position.The push rod traveled toward the distal end deploying completely the stent as expected.The stent expanded presenting no anomalies or damages.Per infrared spectroscopy (ftir) results: two infrared spectra were taken from the ¿smooth section¿ as reference (black and red color line), two more were taken from the rough sections (blue and pink line).Therefore, according to figure 1, the bands present in the different sections of the material are similar, which means that in both sections¿ material is the same the found residuals belongs to the coating of the outer body (polyamide enamel), moreover, no contaminant was found outside the composition of the catheter itself.A second infrared spectroscopy (ftir) analysis was performed with the following results: a second infrared spectroscopy (ftir) analysis was required with the following outcomes: the catheter was analyzed taking a pair of spectra along the catheter.Both spectra are slightly different, however correspond to the same catheter composition.In conclusion, there is no contamination in the catheter, the smooth section shows the spectrum in red color (in figure i lower side as: pc1040rxc-c), and the rough section shows the spectrum in black color (in figure i lower side as: pc1040rx-r1).In conclusion both ftir analysis confirm that there are no contamination and the material observed on the rough section belongs to the coating from the outer body (polyamide enamel).All the material observed on the pictures is inherent to the outer body and is part of the coating of the body catheter (polyamide enamel).A product history record (phr) review of lot 18014006 revealed no anomalies or non-conformances during the manufacturing and inspection processes that can be associated with the reported event.The reported ¿stent delivery system (sds)-ses ~ deployment difficulty - unable¿ was not confirmed.The functional test was performed successfully, and the stent was deployed as expected.The reported ¿stent delivery system (sds)-ses ~ deployment difficulty - premature deployment¿ was confirmed, the unit was returned partially deployed.According to the instructions for use (ifu) ¿preparation of stent delivery system: caution: the stent delivery system is shipped with the tuohy borst valve open.Be careful not to prematurely deploy the stent during preparation.Prep the device in the tray per instructions below.Close the tuohy borst valve prior to removing the device from the tray.¿ additionally, the instructions for use (ifu) states ¿note: if resistance is met during delivery system introduction, the system should be withdrawn and another system should be used.¿ vessel characteristics and or user interaction with the device may have led to the reported events.It should be noted that during product analysis, the hemostasis valve was returned tightly closed.Indicating that the end user manipulated the device since the stent delivery system is shipped with the tuohy borst valve open.Neither the phr review nor the product analysis suggests that the reported events could be related to the manufacturing process of the unit.Therefore, no corrective or preventive actions will be taken.

• Brand Name: 10X40MM PRECISE PRO RX US CAROTID SYST
• Type of Device: STENT, CAROTID
• Manufacturer (Section D): CARDINAL HEALTH MEXICO 244 S DE RL DE CV; santiago troncoso 808; juarez 32574 ; MX 32574
• Manufacturer (Section G): CARDINAL HEALTH MEXICO 244 S DE RL DE CV; santiago troncoso 808; juarez 32574 ; MX 32574
• Manufacturer Contact: karla castro ; miami lakes, FL 33014 ; 7863138372
• MDR Report Key: 12952471
• MDR Text Key: 285709017
• Report Number: 9616099-2021-05121
• Device Sequence Number: 1
• Product Code: NIM
• UDI-Device Identifier: 20705032036556
• UDI-Public: (01)20705032036556(17)230331(10)18014006
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: P030047
• 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: 02/09/2022

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: 03/31/2023
• Device Model Number: N/A
• Device Catalogue Number: PC1040RXC
• Device Lot Number: 18014006
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/27/2021
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 11/12/2021
• Initial Date FDA Received: 12/07/2021
• Supplement Dates Manufacturer Received: 12/22/2021; 01/18/2022
• Supplement Dates FDA Received: 01/13/2022; 02/09/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/06/2021
• 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: SHEATH: 6F AXCELGUIDE, MEDIKIT
• Patient Age: 70 YR
• Patient Sex: Male