MAUDE Adverse Event Report: CORDIS CORPORATION PRECISE PRO RX US CAROTID SYST; STENT, CAROTID

Catalog Number PC1040RXC

Device Problem Detachment of Device or Device Component (2907)

Patient Problem No Code Available (3191)

Event Date 04/22/2019

Event Type  Injury  

Manufacturer Narrative

A review of the manufacturing documentation associated with lot (17845456) presented no issues during the manufacturing process that can be related to the reported event.Additional information is pending and will be submitted within 30 days upon receipt.(b)(4).

Event Description

As reported, following the stent deployment, the distal end of a precise pro rx got separated when the physician removed it, feeling slight resistance.The separated fragments were removed from the patient¿s body with a gooseneck wire.The doctor commented that this issue might have caused by residence from extraneous factors.There was no reported patient injury and the procedure was completed.The target lesion was the internal carotid artery.The precise pro was used during a percutaneous transluminal angioplasty (pta) case.There was no anomalies confirmed on the device prior to and during the procedure.Initially, a balloon catheter was inflated, a guidewire and the precise pro rx was inserted and implanted.The device was stored as per the instructions for use (ifu).The device was prepped per the ifu.There was no difficulty advancing the device to the lesion.The separated part of the device was less than 1-centimetres (cm) at distal end tip part only.The separated distal end(s) will be returned for analysis.

Manufacturer Narrative

After further review of additional information received have been updated accordingly.During an internal carotid artery procedure, following the stent deployment, the distal end of a precise pro rx separated when the physician encountered slight resistance when removing the device.The separated fragments were removed from the patient¿s body with a gooseneck wire and the procedure was completed successfully.The target lesion was the internal carotid artery.The precise pro was used during a percutaneous transluminal angioplasty (pta) case.There were no anomalies noted on the device prior to and during the procedure.Initially, a balloon catheter was inflated, a guidewire and the precise pro rx was inserted and implanted.The device was stored as per the instructions for use (ifu).The device was prepped per the ifu.There was no difficulty advancing the device to the lesion.No other information was reported.The device was returned for analysis.A non-sterile ¿precise pro rx us carotid syst¿ was received for analysis inside of a clear plastic bag.The device was unpacked and placed on a metallic tray to be visually inspected.Per visual inspection, a distal tip separation was noted.Also, a kinked/bent condition was noted on the outer shaft at 8 cm from the edge of the identification (id) band.No other damages or anomalies were noted.Per sem analysis, the distal tip of the inner body was confirmed to be separated.The other separated matching portion of the distal tip was not received for analysis.The observed separated condition of the distal tip of the inner body showed irregular edges and elongations at the inner body at the area of separation.The irregular edges and elongations noted are commonly associated with separations caused by material tensile overload.Therefore, it is thought that the inner body was induced to a tensile force that exceeded the material yield strength prior to the separation.No other issues were noted during the sem analysis.A product history record (phr) review of lot 17845456 revealed no anomalies or non-conformance during the manufacturing and inspection processes that can be associated with the reported event.The phr review does not suggest that the event reported by the customer could be related to the manufacturing process.The reported ¿catheter tip - separated - in patient" was confirmed.A separated condition was noted on the received device, also, a kinked/bent condition was noted on the outer shaft.The irregular edges and elongations noted are commonly associated with separations caused by material tensile overload.Therefore, it is thought that the inner body was induced to a tensile force that exceeded the material yield strength prior to the separation.The exact cause of the reported event could not be conclusively determined during the analysis, procedural factors or handling process may have contributed to the damaged noted.Per the instructions for use (ifu), which is not intended as a mitigation, ¿while using fluoroscopy, withdraw the entire delivery system as one unit, over the guidewire and out of the body.Remove the delivery device from the guidewire.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.(do not remove guidewire.).¿ neither the product analysis nor the phr review suggests that the events could be related to the manufacturing process; therefore, no corrective action will be taken at this time.

• Brand Name: PRECISE PRO RX US CAROTID SYST
• Type of Device: STENT, CAROTID
• Manufacturer (Section D): CORDIS CORPORATION; 14201 nw 60th ave; miami lakes FL 33014
• MDR Report Key: 8624702
• MDR Text Key: 145534649
• Report Number: 9616099-2019-02970
• Device Sequence Number: 1
• Product Code: NIM
• UDI-Device Identifier: 20705032036556
• UDI-Public: 20705032036556
• Combination Product (y/n): N
• PMA/PMN Number: P030047
• 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: 06/10/2019

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?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 01/31/2021
• Device Catalogue Number: PC1040RXC
• Device Lot Number: 17845456
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/06/2019
• Initial Date Manufacturer Received: 04/23/2019
• Initial Date FDA Received: 05/20/2019
• Supplement Dates Manufacturer Received: 04/23/2019
• Supplement Dates FDA Received: 06/10/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: BALLOON CATHETER (UNKNOWN); GOOSENECK WIRE; GUIDE WIRE (UNKNOWN); BALLOON CATHETER (UNKNOWN); GOOSENECK WIRE; GUIDE WIRE (UNKNOWN)
• Patient Outcome(s): Required Intervention