MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION FILTERWIRE EZ; TEMPORARY CORONARY SAPHENOUS VEIN BYPASS GRAFT FOR EMBOLIC PROTECTION

Model Number 7576

Device Problems Material Integrity Problem (2978); Adverse Event Without Identified Device or Use Problem (2993)

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

Event Date 12/11/2023

Event Type  malfunction  

Manufacturer Narrative

E1.(b)(6).

Event Description

It was reported that the tip separated.The 85% stenosed target lesion was located in the mildly tortuous and moderately calcified internal carotid artery.Two 190 cm filterwire ez were selected for use.A normal puncture was done and the 8f guide catheter was placed into the common carotid artery about 3cm from the beginning of c1.Then the first filter was deployed and was taken out according to normal operations.However, when the body and delivery sheath of the filter were observed, it was found that there was a little kinked in the middle of the push guide wire of the filter, and then the guidewire at the head of the filter was shaped.After shaping, it is found that the tip guide wire coil structure was separated from the filter connection, so it was replaced with another of the same filter.The second filter was then taken out normally and was successfully delivered.However, the coil structure of the tip end of the guide wire was also separated from the connection position of the filter body in the shaping process.Primed and recycled in the salt water and deployed, and it was found that the filter body could not be recovered into the conveyor sheath.Therefore, different batches of filter were replaced.As per physicians opinion unstable tip coil structure may have caused the separation.There were no complications reported and the patient was stable after the procedure.

Manufacturer Narrative

Device evaluated by mfr: the device was returned for evaluation.The wire returned inside the delivery sheath and the filter bag came back in deployed state.Also, the retrieval sheath was returned.The spring tip was bent and stretched, and the sheath was damaged.A part of the box was returned, and it was observed that the box label information matches with the complaint information.For microscope inspection, under microscope magnification the spring tip was bent and stretched.The sheath was damaged.Sheathing/unsheathing could not be performed, since the sheath was damaged.E1.Initial reporter facility name- (b)(6).

Event Description

It was reported that the tip separated.The 85% stenosed target lesion was located in the mildly tortuous and moderately calcified internal carotid artery.Two 190 cm filterwire ez were selected for use.A normal puncture was done and the 8f guide catheter was placed into the common carotid artery about 3cm from the beginning of c1.Then the first filter was deployed and was taken out according to normal operations.However, when the body and delivery sheath of the filter were observed, it was found that there was a little kinked in the middle of the push guide wire of the filter, and then the guidewire at the head of the filter was shaped.After shaping, it is found that the tip guide wire coil structure was separated from the filter connection, so it was replaced with another of the same filter.The second filter was then taken out normally and was successfully delivered.However, the coil structure of the tip end of the guide wire was also separated from the connection position of the filter body in the shaping process.Primed and recycled in the salt water and deployed, and it was found that the filter body could not be recovered into the conveyor sheath.Therefore, different batches of filter were replaced.As per physicians opinion unstable tip coil structure may have caused the separation.There were no complications reported and the patient was stable after the procedure.

• Brand Name: FILTERWIRE EZ
• Type of Device: TEMPORARY CORONARY SAPHENOUS VEIN BYPASS GRAFT FOR EMBOLIC PROTECTION
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 300 boston scientific way; marlborough MA 01752
• Manufacturer (Section G): BOSTON SCIENTIFIC CORPORATION; 2546 calle primera; alajuela ; CS
• Manufacturer Contact: rachel shields ; 4100 hamline ave n; arden hills, MN 55112 ; 6512422111
• MDR Report Key: 18436967
• MDR Text Key: 331816141
• Report Number: 2124215-2023-71534
• Device Sequence Number: 1
• Product Code: NFA
• Combination Product (y/n): N
• Reporter Country Code: CH
• PMA/PMN Number: K063313
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Health Professional,Company Representative,Distributor
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 02/20/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/03/2024
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 7576
• Device Catalogue Number: 7576
• Device Lot Number: 0031932332
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/01/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/30/2023
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Age: 64 YR
• Patient Weight: 65 KG