MAUDE Adverse Event Report: CARDINAL HEALTH MEXICO PRECISE PRO RX US CAROTID SYST; STENT, CAROTID

Model Number PC0840RXC

Device Problems Material Frayed (1262); Detachment of Device or Device Component (2907); Material Split, Cut or Torn (4008)

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

Event Date 03/22/2021

Event Type  malfunction  

Manufacturer Narrative

A review of the device history record (dhr) associated with lot 17969954 revealed no anomalies during the manufacturing and inspection processes that can be associated with the reported event.Additional information is pending and will be sent in upon 30 days after receipt.

Event Description

As reported, the catheter tip of the precise pro rapid exchange (rx) carotid self-expanding stent (ses) delivery system was noted to have frayed distal end.The device was not placed in the patient¿s body.The defective device was recognized during device prep and the device was removed from the procedure.There was no reported patient injury.The device was stored per labelling and opened in sterile field.The device was stored for approximately eighteen months.The device was stored, handled and prepped per the instructions for use (ifu).The device was never placed on the wire.The procedure was completed using another precise.The device is expected to be returned for analysis.

Manufacturer Narrative

After further review of additional information received the following sections d8,d9, g3, g6, h2 and h3 have been updated accordingly.The device has been returned for evaluation, but the manufacture report is not yet available.Additional information is pending and will be sent in upon 30 days after receipt.

Manufacturer Narrative

After further review of the additional information received the following sections g3,g6, h2,h3 and h6 have been updated accordingly.The catheter tip of the precise pro rapid exchange (rx) carotid self-expanding stent (ses) delivery system was noted to have frayed distal end.The device was not placed in the patient¿s body.The defective device was recognized during device prep and the device was removed from the procedure.Per visual analysis, the guide wire lumen (inner shaft) was observed elongated and separated damaged at 21.0 cm from the distal tip area.The device was stored per labelling and opened in sterile field.The device was stored for approximately eighteen months.The device was stored, handled and prepped per the instructions for use (ifu).The device was never placed on the wire.The procedure was completed using another precise.There was no reported patient injury.The device was returned for analysis.One non-sterile (b)(4) precise pro rx us carotid stent delivery system was received for analysis inside a plastic bag.The y valve of the unit was received locked/ closed along with an unknown stopcock valve attached.Per visual analysis, the unit was received in a non-deployed condition (the stent was in place).However, the guide wire lumen (inner shaft) was observed elongated and separated damaged at 21.0 cm from the distal tip area.Additionally, a kink was observed at 6.0 cm from the distal tip area.No original packaging was returned for analysis, as to determine if the damages observed could be caused due to improper packaging.No other anomalies were found.Per microscopic analysis, the precise pro rx guide wire lumen (inner shaft) separated area was observed under the vision system and the separated section of the unit presented elongations and frayed edges.The evidence of elongations and frayed edges characteristics suggest that the unit was submitted to a strong application of a tension force that induced the separation.Also, the kink found on the body shaft of the unit was magnified observed.No other issues were noted during the microscopic analysis.A product history record (phr) review of lot 17969954 revealed no anomalies or non-conformances during the manufacturing and inspection processes that can be associated with the reported event.The reported ¿catheter tip-frayed/split/torn - during prep¿ was not confirmed since no damages were observed on the tip of the unit.However, the "guidewire lumen (inner shaft)-separated" was confirmed.Due to the twisted damaged and separated condition of the unit the way it was returned for analysis.Additionally, a severe kink was observed at 6.0 cm from the distal tip area.Nonetheless, the exact cause of the severe kink damage, the twisted damaged and separated condition of the unit could not be conclusively determined during the product analysis.Per the observed damaged condition of the unit (the way it was received for analysis) a probable application of a twisting tension force that induced the damaged and separated conditions on the unit can be considered.It is reasonable to consider that the tension force noted during the device analysis was the result of the user¿s interaction with the device during device preparation or the user returning the device in improper packaging.As the device was not returned housed in its original packaging.Additionally, it was concluded during the investigation conducted that the user reported noticing the anomaly during device preparation.If an anomaly is noted on the device during device preparation, the instructions for use (ifu) states that the device should not be used.According to the instructions for use, which is not intended as a mitigation of risk, ¿after careful inspection of the pouch looking for damage to the sterile barrier, carefully peel open the pouch and remove the tray.If it is suspected that the sterility or performance of the device has been compromised, the device should not be used.¿ 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: PRECISE PRO RX US CAROTID SYST
• Type of Device: STENT, CAROTID
• Manufacturer (Section D): CARDINAL HEALTH MEXICO; av prado sur 150 2d0 piso; ciudad de mexico 11000 ; MX 11000
• MDR Report Key: 11693182
• MDR Text Key: 248235249
• Report Number: 9616099-2021-04437
• Device Sequence Number: 1
• Product Code: NIM
• UDI-Device Identifier: 20705032036495
• UDI-Public: 20705032036495
• Combination Product (y/n): N
• PMA/PMN Number: P030047
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Type of Report: Initial,Followup,Followup
• Report Date: 07/21/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/20/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 08/31/2022
• Device Model Number: PC0840RXC
• Device Catalogue Number: PC0840RXC
• Device Lot Number: 17969954
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/03/2021
• Date Manufacturer Received: 07/02/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: UNK.