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

Catalog Number	601814RMC
Medical Device Problem Code	Difficult or Delayed Positioning (1157)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/02/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A review of the manufacturing documentation associated with lot 35269680 presented no issues during the manufacturing process that can be related to the reported event.Additional information is pending and will be submitted within 30 days upon receipt.
Event or Problem Description
As reported, the peel away part of the 6mm angioguard rx would not peel away.It was removed and a second one was used.There was no reported injury to the patient.The product was stored and handled per the instructions for use (ifu).The product was inspected and prepped per the ifu.There was nothing unusual noted about the device prior to use.The proximal end of the deployment sheath was in contact with the torque nut prior to removing the device from the coil dispenser.Upon opening the package, the deployment sheath tip was still fully seated in the filter basket introducer.There was no difficulty encountered while flushing the filter introducer and deployment sheath.Saline was noted to be within the coil dispenser at the green deployment sheath hub.The anti-migration clip located closest to the filter introducer was left in place until after the filter basket was docked into the deployment sheath.There was no difficulty noted while docking the filter basket into the deployment sheath.The device will be returned for evaluation.
Event or Problem Description
As reported, the peel away part of the 6mm angioguard rx would not peel away.It was removed and a second one was used.There was no reported injury to the patient.The product was stored and handled per the instructions for use (ifu).The product was inspected and prepped per the ifu.There was nothing unusual noted about the device prior to use.The proximal end of the deployment sheath was in contact with the torque nut prior to removing the device from the coil dispenser.Upon opening the package, the deployment sheath tip was still fully seated in the filter basket introducer.There was no difficulty encountered while flushing the filter introducer and deployment sheath.Saline was noted to be within the coil dispenser at the green deployment sheath hub.The anti-migration clip located closest to the filter introducer was left in place until after the filter basket was docked into the deployment sheath.There was no difficulty noted while docking the filter basket into the deployment sheath.The device will be returned for evaluation.
Additional Manufacturer Narrative
As reported, the peel away part of the 6mm angioguard rx embolic protection device (epd) would not peel away.It was removed and a second one was used.There was no reported injury to the patient.The product was stored, inspected, handled, and prepped per the instructions for use (ifu).There was nothing unusual noted about the device prior to use.The proximal end of the deployment sheath was in contact with the torque nut prior to removing the device from the coil dispenser.Upon opening the package, the deployment sheath tip was still fully seated in the filter basket introducer.There was no difficulty encountered while flushing the filter introducer and deployment sheath.Saline was noted to be within the coil dispenser at the green deployment sheath hub.The anti-migration clip located closest to the filter introducer was left in place until after the filter basket was docked into the deployment sheath.There was no difficulty noted while docking the filter basket into the deployment sheath.A non-sterile unit of a ¿6mm basket, medium support, angioguard rx for us carotid¿ was received for product analysis.Per visual analysis, the returned components were the deployment sheath and the embolic capture guidewire (ecgw) system.The rest of the components were not returned for analysis.The ecgw system was received inserted inside the deployment sheath and the peel away sheath was peeled until the yellow mark.No other outstanding details were observed with the returned parts.A functional test was performed by peeling away the rest of the deployment sheath.Resistance was felt at several points; however, it was found that the deployment sheath was full of dried body fluids, making the peeling process difficult.Per microscopic analysis, the peel-away sheath was inspected under the vision system to obtain a magnified image of its condition and it was found twisted and opened.In addition, an excessive amount of dried body fluids was observed.A product history record (phr) review of lot 35269680 revealed no anomalies or non-conformances during the manufacturing and inspection processes that can be associated with the reported event.The reported event of ¿deployment (delivery) sheath-peeling difficulty (rx only)¿ was confirmed through analysis of the returned device due to the resistance experienced during the functional test.However, the exact cause of the issue experienced by the customer could not be conclusively determined during analysis.Based on the information available for review and product analysis, it is difficult to determine what factors may have contributed to the peeling difficulty reported, especially since the resistance experienced during functional analysis was due to the dried body fluids inside.However, procedural/handling factors may have contributed to the event experienced as evidenced by the twisted and opened condition of the peeling deployment sheath received noted during analysis.According to the precautions in the safety information of the ifu, ¿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.¿ this product was finally inspected at lake region medical and was determined to be acceptable.Neither the phr review, nor the product analysis suggest that the event experienced by the customer could be related to the design or manufacturing process of the unit.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: 18020303
• Report Number: 1016427-2023-05569
• Device Sequence Number: 20467414
• Product Code: NTE
• UDI-Device Identifier: 10705032056748
• UDI-Public: (01)10705032056748(17)250531(10)35269680
• 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 Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 12/14/2023

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: 35269680
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/13/2023
• 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
• Supplement Date Received by Manufacturer: 12/06/2023
• Initial Report FDA Received Date: 10/27/2023
• Supplement Report FDA Received Date: 12/14/2023
• 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: ANGIOGUARD 6MM.
• Patient Sex: Unknown
• Patient Ethnicity: Non Hispanic
• Patient Race: White