MAUDE Adverse Event Report: CORDIS CORPORATION 6F .070 XB 3.5 100CM; CATHETER, PERCUTANEOUS

Model Number 67005400

Device Problems Material Frayed (1262); Material Split, Cut or Torn (4008)

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

Event Date 05/31/2021

Event Type  malfunction  

Manufacturer Narrative

A review of the manufacturing documentation associated with lot 18000514 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.

Event Description

As reported, the head-end of 6f.070 3.5 100cm vista brite tip extra back-up (xb) guiding catheter was frayed/split/torn.Therefore, the device was replaced with another vista brite tip catheter to complete the operation.This event had no effect on the patient and there was no reported patient injury.The patient had more than 80% stenosis of right coronary artery and percutaneous coronary intervention (pci) was needed.The device was stored in the lab according to the ifu for 15 days.The device was stored and handled per the ifu.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 and h6.As reported, the head-end of 6f.070 3.5 100cm vista brite tip extra back-up (xb) guiding catheter was frayed/split/torn-in patient.Therefore, the device was replaced with another vista brite tip catheter to complete the operation.This event had no effect on the patient and there was no reported patient injury.The patient had more than 80% stenosis of right coronary artery and percutaneous coronary intervention (pci) was needed.The device was stored and handled per the ifu.One non-sterile unit of catheter 6f.070 xb 3.5 100cm was received for analysis.During the visual inspection, several kinked conditions were found located at approximately 2.8, 27.1, 55.1, and 81.9 cm from the distal tip.No other anomalies were found along the device.Dimensional analysis was performed to verify the correct catheter inner diameter (id) and outer diameter (od).Measurements were taken near the damages and verified against the ppe specification.Dimensional analysis result was found within specification.A product history record (phr) review of lot 18000514 revealed no anomalies or non-conformances during the manufacturing and inspection processes that can be associated with the reported event.The complaint reported by the customer as ¿brite tip/distal tip - frayed/split/torn - in-patient¿ was not confirmed since no split or torn damage was found on the tip however, several kinked conditions were noted on the body of the catheter.The exact cause of the conditions found could not be determined during the analysis.Procedural/handling factors or vessel characteristics such as persistent catheter torquing and/or vessel tortuosity may have contributed to the reported event.According to the instructions for use (ifu), although not intended as a mitigation of risk, ¿if strong resistance is met during manipulation, discontinue the procedure and determine the cause of the resistance before proceeding.If the cause of the resistance cannot be determined, withdraw the catheter.Torquing the guiding catheter excessively while kinked may cause damage which could result in possible separation along the catheter shaft.Should the guiding catheter shaft become severely kinked, withdraw the entire system (guiding catheter, guidewire, and catheter sheath introducer).¿ neither the phr review nor the product analysis suggests that the reported event could be related to the manufacturing process of the unit.Therefore, no corrective or preventive actions will be taken at this time.

• Brand Name: 6F .070 XB 3.5 100CM
• Type of Device: CATHETER, PERCUTANEOUS
• Manufacturer (Section D): CORDIS CORPORATION; 14201 nw 60 avenue; miami lakes FL 33014
• MDR Report Key: 12136397
• MDR Text Key: 260515341
• Report Number: 9616099-2021-04692
• Device Sequence Number: 1
• Product Code: DQY
• UDI-Device Identifier: 20705032020166
• UDI-Public: 20705032020166
• Combination Product (y/n): N
• PMA/PMN Number: K021593
• 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: 07/21/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/08/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 01/31/2024
• Device Model Number: 67005400
• Device Catalogue Number: 67005400
• Device Lot Number: 18000514
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/15/2021
• Date Manufacturer Received: 07/15/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 74 YR
• Patient Weight: 67