MAUDE Adverse Event Report: CORDIS CORPORATION PRECISE PRO RX 8X40; STENT, CAROTID

Catalog Number PC0840XCE

Device Problem Crack (1135)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 03/29/2018

Event Type  malfunction  

Manufacturer Narrative

A review of the manufacturing documentation associated with this lot 17706478 presented no issues during the manufacturing process that can be related to the reported complaint.This device is not available for testing and evaluation.Additional information is pending and will be submitted within 30 days upon receipt.

Event Description

As reported, the delivery shaft of the precise pro rx 8 x 40 was fractured.There was no patient injury reported and the product will not be returned for analysis due to infectious disease.The product was stored and handled according to the instructions for use (ifu).There was no damage noted to the packaging of the devices.The device was stored in the lab according to ifu.The product was stored one month before it is distributed to the cath lab.There was no damage to the device noticed prior to opening the package.There was no difficulty removing the device from the sterile packaging.The delivery shaft crack was noted during the operation.The device was not in more than one piece.The procedure was completed successfully.

Manufacturer Narrative

As reported, during a procedure the delivery shaft of the precise pro rx 8 x 40 was fractured.There was no patient injury reported and the product will not be returned for analysis due to infectious disease.The product was stored and handled according to the instructions for use (ifu).There was no damage noted to the packaging of the devices.The device was stored in the lab according to ifu.The product was stored one month before it is distributed to the cath lab.There was no damage to the device noticed prior to opening the package.There was no difficulty removing the device from the sterile packaging.The delivery shaft crack was noted during the operation.The device was not in more than one piece.The procedure was completed successfully.The product was not returned for analysis.A device history record (dhr) review of lot 17706478 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- cracked could not be confirmed as the device was not returned for analysis.The exact cause could not be determined.The vessel characteristics are unknown.However if the vessel has characteristics of tortuosity or calcification, these may have contributed to the reported event.Neither the dhr nor the information available suggests a design or manufacturing related cause for the reported burst; therefore, no corrective/preventive action will be taken.According to the instructions for use, which is not a mitigation of risk ¿extract the stent delivery system from the tray.Examine the device for any damage.Evaluate the distal end of the catheter to ensure that the stent is contained within the outer sheath.Do not use if the stent is partially deployed.Note: if resistance is met during delivery system introduction, the system should be withdrawn and another system should be used.Note: if any resistance is met during delivery system withdrawal, advance the outer sheath until the outer sheath marker contacts the catheter tip and withdraw the system as one unit.¿ neither the dhr review nor the product analysis suggests that the event experienced by the customer could be related to the manufacturing process; therefore, no corrective/preventive action will be taken at this time.

• Brand Name: PRECISE PRO RX 8X40
• Type of Device: STENT, CAROTID
• Manufacturer (Section D): CORDIS CORPORATION; 14201 nw 60th avenue; miami lakes FL 33014
• MDR Report Key: 7454400
• MDR Text Key: 106411517
• Report Number: 9616099-2018-02087
• Device Sequence Number: 1
• Product Code: NIM
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional
• Type of Report: Initial,Followup
• Report Date: 05/22/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/24/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 07/31/2019
• Device Catalogue Number: PC0840XCE
• Device Lot Number: 17706478
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 04/24/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: ANTIHYPERTENSIVES, ANTIHEPATITIS DRUG
• Patient Outcome(s): Hospitalization; Life Threatening
• Patient Age: 65 YR
• Patient Weight: 80