MAUDE Adverse Event Report: CORDIS CORPORATION 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 02/01/2021

Event Type  Injury  

Manufacturer Narrative

A review of the manufacturing documentation associated with lot 17929128 presented no issues during the manufacturing process that can be related to the reported event.This device is available for analysis but the engineering report is not yet available.However, it will be submitted within 30 days upon receipt.Additional information is pending and will be submitted within 30 days upon receipt.

Event Description

As reported, a 10mm x 40mm precise pro rapid exchange (rx) carotid self-expanding stent (ses) delivery system was implanted.After that, a 3 x 40mm non-cordis balloon catheter was inserted to be inflated as post dilation.However, during delivery to the lesion, there was resistance.When checked under fluoroscopy, something like tip of the precise pro rx was confirmed.The shaft of the precise pro rx was checked outside the body and confirmed that there was no tip at the distal end.The unknown guidewire was deflated at 2-3mm, the tip was put into a non-cordis guiding catheter.The guiding catheter was removed from the patient body and the tip of the precise pro were successfully removed.After that, the non-cordis guiding catheter was implanted again at the common carotid artery.The unknown guidewire was implanted at the distal lesion and inflated at 5mm.A 4 x 30mm non-cordis balloon catheter was inflated as post dilation and aspirated with a suction catheter.Good dilation was confirmed by contrast enhancement, and the procedure was completed.There was no patient injury.Initially, the target lesion was the left carotid artery which has stenosis.The left common carotid artery had mild calcification, no tortuosity, and no angulation.A femoral approach was made.A 9f non-cordis guiding catheter was implanted at the common carotid artery.An unknown guidewire was implanted at the distal lesion and inflated at 5mm.Other procedural details were requested but are unknown, unavailable, or not applicable.The patient had no infectious disease.The device will be returned for evaluation.

Manufacturer Narrative

After further review of additional information received the following sections have been updated accordingly: g3, g6, h1, h2, h3, h6, and h10.Complaint conclusion: a precise pro 10mm x 40mm rapid exchange (rx) carotid self-expanding stent (ses) delivery system was implanted.After that, a non-cordis 3 x 40mm balloon catheter was inserted to be inflated as post dilation.However, during delivery to the lesion, there was resistance.When checked under fluoroscopy, something like tip of the precise pro rx was confirmed.The shaft of the precise pro rx was checked outside the body and confirmed that there was no tip at the distal end.The unknown guidewire was deflated at 2-3mm, the tip was put into a non-cordis guiding catheter.The guiding catheter was removed from the patient body and the tip of the precise pro rx was successfully removed.After that, the non-cordis guiding catheter was implanted again at the common carotid artery.The unknown guidewire was implanted at the distal lesion and inflated at 5mm.A 4 x 30mm non-cordis balloon catheter was inflated as post dilation and aspirated with a suction catheter.Good dilation was confirmed by contrast enhancement, and the procedure was completed.Initially, the target lesion was the left carotid artery which has stenosis.The left common carotid artery had mild calcification, no tortuosity, and no angulation.A femoral approach was made.A 9f non-cordis guiding catheter was implanted at the common carotid artery.An unknown guidewire was implanted at the distal lesion and inflated at 5mm.The patient had no infectious disease.There was no patient injury.The device was returned for analysis.Per visual analysis, one non-sterile precise pro rx carotid system was received for analysis inside a plastic bag.No original packaging was returned.A non-cordis embolic protection system and a non-cordis capture sheath were received inside the same bag.The valve of the unit was received closed.Per visual analysis, the stent of the unit was observed deployed but was not received along the unit.The wire lumen was observed separated from the distal tip.Distal tip was observed inserted into the non-cordis embolic protection system, as received.An acceptable adhesive quantity was observed inside the tip¿s glue port.Nevertheless, due to the condition received of the tip, visual analysis couldn¿t determine if the correct amount of adhesive was applied through the entire section between the wire lumen and the tip.The hypo tube rod was observed bent, as received.No other anomalies were observed.A product history record (phr) review of lot 17929128 revealed no anomalies or non-conformances during the manufacturing and inspection processes that can be associated with the reported event.The reported ¿catheter tip - separated - in patient¿ was confirmed since the distal tip was observed separated from the wire lumen.An acceptable adhesive quantity was observed inside the tip¿s glue port.Nevertheless, due to the condition received of the tip, visual analysis couldn¿t determine if the correct amount of adhesive was applied throughout the entire section between the wire lumen and the tip.After the physical evaluation of the unit, it was determined by the product engineering team (pet) that the tip separation event was a manufacturing related as the physical evaluation couldn¿t conclusively determine if the correct amount of adhesive was applied through the entire section between the wire lumen and the tip.According to the instructions for use, which is not intended as 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.¿ the product analysis suggests that the event experienced by the customer could be related to the manufacturing process; therefore, a corrective/preventive 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 60 avenue; miami lakes FL 33014
• MDR Report Key: 11386215
• MDR Text Key: 233788095
• Report Number: 9616099-2021-04299
• 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: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 03/23/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/26/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 01/31/2022
• Device Model Number: N/A
• Device Catalogue Number: PC1040RXC
• Device Lot Number: 17929128
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/12/2021
• Date Manufacturer Received: 03/19/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: BALLOON CATHETER (3-40MM COYOTE, BOSTON SCIENTIFIC; BALLOON CATHETER (4-30MM STERLING, BOSTON SCIENTIF; GUIDING CATHETER (9F OPTIMO, TOKAI MEDICAL PRODUCT; GUIDING CATHETER (OPTIMO); UNKNOWN GUIDEWIRE; BALLOON CATHETER (3-40MM COYOTE, BOSTON SCIENTIFIC; BALLOON CATHETER (4-30MM STERLING, BOSTON SCIENTIF; GUIDING CATHETER (9F OPTIMO, TOKAI MEDICAL PRODUCT; GUIDING CATHETER (OPTIMO); UNKNOWN GUIDEWIRE
• Patient Outcome(s): Required Intervention