MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION SMALL PERIPHERAL CUTTING BALLOON; CATHETERS, TRANSLUMINAL CORONARY ANGIOPLASTY, PERCUTANEOUS

Model Number 24658

Device Problems Difficult to Remove (1528); Material Deformation (2976)

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

Event Date 09/28/2022

Event Type  malfunction  

Manufacturer Narrative

Initial reporter city: (b)(6).

Event Description

It was reported that the device was difficult to remove.The 90% stenosed target lesion was located in the moderately tortuous and moderately calcified below the knee artery.A 2.00mm/1.5cm/140cm small peripheral cutting balloon was selected for use.Upon withdrawal, the shaft was caught in the guidezilla and could not be removed.Furthermore, shaft kink was noted.An attempt was made to remove the device from the sheath together with the guidezilla, but it still could not be removed.Finally, the devices were removed together with the sheath.The procedure was completed with this device.No patient complications reported.

Event Description

It was reported that the device was difficult to remove.The 90% stenosed target lesion was located in the moderately tortuous and moderately calcified below the knee artery.A 2.00mm/1.5cm/140cm small peripheral cutting balloon was selected for use.Upon withdrawal, the shaft was caught in the guidezilla and could not be removed.Furthermore, shaft kink was noted.An attempt was made to remove the device from the sheath together with the guidezilla, but it still could not be removed.Finally, the devices were removed together with the sheath.The procedure was completed with this device.No patient complications reported.

Manufacturer Narrative

E1 - initial reporter city: (b)(6).Device evaluated by manufacturer: the device was returned for analysis.The device was received loaded on to the customers guidewire and advanced through the customers guiding.For investigation purposes the investigator removed the guidewire from the shaft.The investigator was unable to remove the device from the guiding due to severe shaft kinking.A visual examination identified that the balloon had been inflated.The balloon material and blades of the device were visually examined, and no issues were noted that may have potentially contributed to the complaint incident.All blades were fully bonded to the balloon material.A visual investigation identified no damage or any issues with the marker bands or tip of the device that could potentially have contributed to the complaint incident.A visual and tactile examination found the shaft of the device to be severely kinked at more than one location proximal of the guidewire port.This type of damage is consistent with excessive force being applied to the device.

• Brand Name: SMALL PERIPHERAL CUTTING BALLOON
• Type of Device: CATHETERS, TRANSLUMINAL CORONARY ANGIOPLASTY, PERCUTANEOUS
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; two scimed place; maple grove MN 55311
• Manufacturer (Section G): BOSTON SCIENTIFIC IRELAND LIMITED; ballybrit business park; galway ; EI
• Manufacturer Contact: jay johnson ; 4100 hamline ave n; arden hills, MN 55112 ; 6515810888
• MDR Report Key: 15628811
• MDR Text Key: 306603688
• Report Number: 2124215-2022-41115
• Device Sequence Number: 1
• Product Code: NWX
• Combination Product (y/n): N
• Reporter Country Code: JA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative,Distributor
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 11/17/2022

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 Operator: Health Professional
• Device Expiration Date: 10/20/2022
• Device Model Number: 24658
• Device Catalogue Number: 24658
• Device Lot Number: 0024629405
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 09/30/2022
• Initial Date FDA Received: 10/18/2022
• Supplement Dates Manufacturer Received: 10/26/2022
• Supplement Dates FDA Received: 11/17/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/21/2019
• 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
• Treatment: GUIDE CATHETER-GUIDEZILLA PV6F; GUIDE CATHETER-GUIDEZILLA PV6F; GUIDEWIRE-JUPITER; GUIDEWIRE-JUPITER; INTRODUCER SHEATH-HALO ONE; INTRODUCER SHEATH-HALO ONE