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

Catalog Number	601814REC
Medical Device Problem Codes	Stretched (1601); Unraveled Material (1664)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/16/2023
Type of Reportable Event	Malfunction
Event or Problem Description
As reported, the shapable distal tip of the (ecgw) became coiled up passing through sheath.The distal tip was found to be unraveled/stretched during the product evaluation.Made it impossible to traverse lesion.There was no reported injury to the patient.The device will be returned for evaluation.
Additional Manufacturer Narrative
The shapable distal tip of the (ecgw) became coiled up passing through sheath.The distal tip was found to be unraveled/stretched during the product evaluation.Made it impossible to traverse lesion.There was no reported injury to the patient.The product was returned for analysis.A non-sterile unit of a 6mm basket, extra support, angioguard rx for us carotid was received inside of a clear plastic bag.Per visual analysis the returned components are the deployment sheath, the ecgw system and the torque device.The rest of the components were not returned for analysis.The distal tip of the ecgw was found unraveled.No other outstanding details were observed.Per microscopic analysis the unraveled condition was confirmed.A product history record (phr) review of lot 35269679 revealed no anomalies or non-conformances during the manufacturing and inspection processes that can be associated with the reported event.The reported ¿distal tip (ecgw) - out of shape¿ and ¿distal tip - unraveled stretched¿ were confirmed through analysis of the returned device.The exact cause of the event could not be determined during analysis.Based on the information available for review, procedural or handling factors may have contributed to the event.According to the precautions in the safety information of 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.¿ neither the phr review nor the product analysis suggests that the event experienced by the customer could be related to the manufacturing process; therefore, no corrective/preventive action 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 FL 33014
• Manufacturer (Section G): CORDIS US CORP.; 14201 nw 60 avenue; miami lakes FL 33014
• Manufacturer Contact: karla castro ; 340 lake hazeltine drive; chaska, minnesota 55318 ; 7863138372
• MDR Report Key: 18356754
• Report Number: 1016427-2023-05572
• Device Sequence Number: 20481539
• Product Code: NTE
• UDI-Device Identifier: 10705032056724
• UDI-Public: (01)10705032056724(17)250531(10)35269679
• 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): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 12/19/2023

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: 601814REC
• Device Lot Number: 35269679
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/22/2023
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 12/19/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/06/2023
• 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
• Concomitant Medical Products and Therapy/Usage Dates: UNK.
• Patient Sex: Unknown