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

Model Number 24658

Device Problem Failure to Advance (2524)

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

Event Date 01/24/2023

Event Type  malfunction  

Manufacturer Narrative

Initial reporter facility name: (b)(6) hospital.Device evaluated by mfr: the complaint device was received for product analysis.The device was returned with the balloon protector in place on the device.For investigation purposes the investigator fully removed the protector without issue.A visual examination identified that the balloon was not subjected to positive pressure.The balloon material and blades of the device were visually examined, and no issues were noted.All blades were fully bonded to the balloon material.A visual and tactile examination found the shaft polymer extrusion to be completely detached at the guidewire port.This type of damage is consistent with excessive tensile force being applied to the device.A visual investigation identified no damage or any issues with the markerbands of the device.This concludes the product analysis.

Event Description

Reportable based on device analysis completed on 28feb2023.It was reported that the device had crossing difficulties.The 100% stenosed target lesion was located in the severely tortuous and severely calcified left superficial femoral artery.A 4.00mmx1.5cmx140cm small peripheral cutting balloon was selected for use.During the procedure, it was noted that the device was unable to cross the lesion.The procedure was completed with another of the same device.No complications were reported and the patient was in good condition after the procedure.However, device analysis revealed shaft polymer extrusion completely detached at the guidewire port.

• 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: 16585330
• MDR Text Key: 311756977
• Report Number: 2124215-2023-10543
• 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: Other,Foreign,Health Professional,Company Representative,Distributor
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 03/21/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/21/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 11/04/2023
• Device Model Number: 24658
• Device Catalogue Number: 24658
• Device Lot Number: 0026299690
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/13/2023
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/28/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/04/2020
• 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