MAUDE Adverse Event Report: CORDIS CORPORATION PRECISE PRO RX 9X40; STENT, CAROTID

Model Number PC0940XCE

Device Problem Detachment of Device or Device Component (2907)

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

Event Date 03/19/2021

Event Type  malfunction  

Manufacturer Narrative

One non-sterile precise pro rx 9x40 was received for analysis inside a plastic bag.No original packaging was returned.The valve of the unit was received unlocked.Per visual analysis, the stent was observed deployed from the unit and returned inside the bag.No anomalies were observed on the stent.Blood residues were observed inside the hub and the distal tip.Four kinks were observed on the body/shaft of the unit approximately at 8 cm, 9.5 cm, 36.5 cm and 91.2 cm from the strain relief.Also, two kinks were observed on the outer sheath approximately at 7.7 cm and 8.4 cm from the hub port.The wire lumen was observed separated approximately at 1 mm from the wire lumen pod.No other anomalies were observed (see pictures).Review of the manufacturing documentation associated with the lot # 17912292 was performed and it was found that no defective units were rejected during the final assembly of this lot.No other issues were noted that could be related to the reported complaint.No nonconformance were found for lot 17912292.The phr review does not suggest that the failure experienced by the customer could be related to the manufacturing process.Therefore, no corrective or preventive actions will be taken at this time.The od the unit was measured at different distances per drawing (b)(4), and the results were found within specification.Per microscopic analysis, sem results showed that the separated area of wire lumen of the precise pro rx 9x40 unit presented evidence of elongations and cup and cone shape-like.The elongations and the cup and cone shape-like found on the wire lumen material are commonly associated with separations caused by material tensile overload.Therefore, it is assumed that the wire lumen material was induced to a tensile force that exceeded the wire lumen material yield strength prior to the separation.No other anomalies were observed during sem analysis (see sem report).The complaint reported by the customer as ¿stent delivery system (sds)-ses - tracking difficulty¿ could not be confirmed since the event reported cannot be properly evaluated due to the nature of the complaint.Nevertheless, dimensional test was performed and the results were found within specification.Also, wire lumen was observed separated, as received.Per microscopic analysis, sem results showed that the separated area of the wire presented evidence of elongations and cup and cone shape-like on the wire lumen material.The previously mentioned damages are commonly associated with separations caused by material tensile overload.Therefore, it is assumed that the wire lumen material was induced to a tensile force that exceeded the wire lumen material yield strength prior to the separation.Per the observed damages, it could be suggested that procedural factors and/ or handling process may have contributed to the observed damages of the unit.Also, controls are in place to verify the catheters for the mentioned conditions or any other damages; the produced catheters are inspected 100 % before leaving the facility.Also, several inspections are performed through all the assembly process operations.Refer to (b)(4).The cause of the material separation observed on the wire lumen, the kinks observed on the body/shaft and the kinks observed on the outer sheath could not be conclusively determined during the analysis.Neither the phr review nor the product analysis suggests that the reported failure could be related to the manufacturing process of the unit.Therefore, no corrective or preventive actions will be taken.

Event Description

As reported, the 9mm x 40mm precise pro rapid exchange (rx) self-expanding stent (ses) delivery system was failed to be advanced.A 8f unknown sheath was used.Also a 8f non cordis guidewire was used to complete the procedure.The unknown balloon used for pre-dilation did not inflated when inserting the sds in the catheter balloon.There was no reported patient injury.Negative pressure was applied to the sds.The inflation device was in the neutral position when the system was being advanced/withdrawn.It was confirmed that the balloon was fully deflated prior to withdrawal.Negative pressure was maintained on the inflation device during withdrawal of the system.The guide catheter was not repositioned by advancing or withdrawing over the stent.The stent was not manipulated during prep.The was stent properly mounted on the system when inspected prior to use.The sds was prepped according to ifu guidelines.As per the product evaluation ,the wire lumen was observed separated approximately at 1 mm from the wire lumen pod.The patient had carotid artery stenosis.The device will be returned for evaluation.

• Brand Name: PRECISE PRO RX 9X40
• Type of Device: STENT, CAROTID
• 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: 11900902
• MDR Text Key: 256188534
• Report Number: 9616099-2021-04587
• Device Sequence Number: 1
• Product Code: NIM
• Combination Product (y/n): N
• Reporter Country Code: CH
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 05/28/2021

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: 10/31/2021
• Device Model Number: PC0940XCE
• Device Catalogue Number: PC0940XCE
• Device Lot Number: 17912292
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/14/2021
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 05/11/2021
• Initial Date FDA Received: 05/28/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 11/01/2019
• 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
• Patient Age: 62 YR
• Patient Weight: 145