MAUDE Adverse Event Report: CORDIS US. CORP ANGIOGUARD RX; TEMPORARY CAROTID CATHETER FOR EMBOLIC CAPTURE

Catalog Number	601814RMC
Medical Device Problem Codes	Difficult or Delayed Positioning (1157); Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/14/2023
Type of Reportable Event	Malfunction
Event or Problem Description
As reported, there was an issue was with the peeling mechanism of a 6mm medium support carotid angioguard rx embolic capture guidewire (ecgw) system as the black peel away tubing did not peel properly.When peeled, the peel pattern was not linear, and the black tubing broke away from the wire.The separated segment was able to be removed using a pin and pull removal; however, this caused the filter to move.The procedure was able to be completed and there were no reported injuries to the patient.The target vessel was the internal carotid artery.The device was stored, handled, and prepped per the instructions for use (ifu) and there was no difficulty flushing the filter introducer or deployment sheath.There was nothing unusual about the device prior to use.The filter was able to be removed easily from the patient.The device will be returned for evaluation.
Additional Manufacturer Narrative
A review of the manufacturing documentation associated with lot 35269813 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.
Additional Manufacturer Narrative
Complaint conclusion: there was an issue was with the peeling mechanism of a 6mm medium support carotid angioguard rx embolic capture guidewire (ecgw) system as the black peel away tubing did not peel properly.When peeled, the peel pattern was not linear, and the black tubing broke away from the wire.The separated segment was able to be removed using a pin and pull removal; however, this caused the filter to move.The procedure was able to be completed and there were no reported injuries to the patient.The target vessel was the internal carotid artery.The device was stored, handled, and prepped per the instructions for use (ifu) and there was no difficulty flushing the filter introducer or deployment sheath.There was nothing unusual about the device prior to use.The filter was able to be removed easily from the patient.The device was returned for analysis.A non-sterile ¿6mm basket, medium support, angioguard rx for us carotid¿ was received inside of a clear plastic bag.Device was unpacked to perform the visual evaluation.The returned components are the deployment sheath, the capture sheath, and the ecgw system.The rest of the components were not returned for analysis.The ecgw system is inserted inside the capture sheath.The deployment sheath is partially peeling.No damages or anomalies were observed.No other outstanding details were observed on the returned part.Functionally analysis was performed.A guide wire was inserted on the deployment sheath by the distal tip until it can see it out of the partial peeling area.The peeling process was resumed until the peeling was fully completed.No resistance or anomalies were observed.A product history record (phr) review of lot 35269813revealed no anomalies or non-conformances during the manufacturing and inspection processes that can be associated with the reported event.The reported ¿deployment (delivery) sheath~peeling difficulty (rx only)¿ was not confirmed, no anomalies or resistance was observed on the peeling process during the functional test.The reported ¿deployment (delivery) sheath~separated-from filter basket introducer¿ was not confirmed.None of the returned components present any damages or separation condition.Exact cause of the reported event could not be conclusively determined during the analysis.Procedural/handling factors might have contributed to this issue.According to the instructions for use, ¿guidewires are delicate instruments and should be handled carefully.Prior to use and when possible, during the procedure, inspect the guidewire carefully for coil separation, bends, kinks, or damage of the filter basket assembly.The deployment and capture sheaths are delicate instruments and should be handled carefully.Prior to use, and when possible, during the procedure, inspect the deployment sheath, capture sheath, and capture sheath rx port region (approximately 30 cm from the distal tip) for bends, kinks, or other damage.¿ the product analysis does not suggest that the observed 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: ANGIOGUARD RX
• Common Device Name: TEMPORARY CAROTID CATHETER FOR EMBOLIC CAPTURE
• Manufacturer (Section D): CORDIS US. CORP; 14201 nw 60 avenue; miami lakes, florida 33014
• Manufacturer (Section G): CORDIS US CORP.; 14201 nw 60 avenue; miami lakes, florida 33014
• Manufacturer Contact: karla castro ; 340 lake hazeltine drive; chaska, minnesota 55318 ; 7863138372
• MDR Report Key: 17894313
• Report Number: 1016427-2023-05566
• Device Sequence Number: 3454374
• Product Code: NTE
• UDI-Device Identifier: 10705032056748
• UDI-Public: (01)10705032056748(17)250531(10)35269813
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K062531
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 11/14/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Expiration Date: 05/31/2025
• Device Catalogue Number: 601814RMC
• Device Lot Number: 35269813
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/21/2023
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/14/2023
• Supplement Date Received by Manufacturer: 11/03/2023
• Initial Report FDA Received Date: 10/09/2023
• Supplement Report FDA Received Date: 11/14/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/29/2023
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown