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

Model Number 24658

Device Problem Break (1069)

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

Event Date 11/26/2022

Event Type  malfunction  

Event Description

It was reported that a shaft break occurred.The 95% stenosed target lesion was located in the mildly tortuous and mildly calcified internal shunt forearm vein side.A 4.00mm/1.5cm/140cm small peripheral cutting balloon was selected for use.During the procedure, it was noted that the shaft and the balloon separated.This occurred outside patient.The procedure was completed with another of the same device.No patient complications were reported.

Event Description

It was reported that a shaft break occurred.The 95% stenosed target lesion was located in the mildly tortuous and mildly calcified internal shunt forearm vein side.A 4.00mm/1.5cm/140cm small peripheral cutting balloon was selected for use.During the procedure, it was noted that the shaft and the balloon separated.This occurred outside patient.The procedure was completed with another of the same device.No patient complications were reported.

Manufacturer Narrative

Device evaluated by mfr: the device was returned for evaluation.The device was received in two sections due to a detachment of the shaft.The device was returned with the balloon protector partially removed 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 that may have potentially contributed to the complaint incident.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.The device was received with the balloon protector partially removed on the device.The investigator was unable to apply a vacuum to the device as per preparation instructions due to a shaft break.For investigation purposes the investigator removed the balloon protector with a little resistance experienced as negative pressure could not be applied to the device.The balloon protectors inner diameter was verified at 0.0435 inch using a calibrated pin gauge (ce 48164).This is within the specified range of 0.0420 inches to 0.0435 inches as per drawing 90413508.'balloon protector 3.5mm thru 4mm'.A visual investigation identified no damage or any issues with the markerbands of the device that could have contributed to the complaint incident.No other issues were identified during the product analysis.

• 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: 15978947
• MDR Text Key: 306183085
• Report Number: 2124215-2022-51833
• 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
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 01/27/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/14/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 10/28/2023
• Device Model Number: 24658
• Device Catalogue Number: 24658
• Device Lot Number: 0026261505
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/11/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/28/2020
• 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
• Treatment: GUIDEWIRE: TRANSEND.; GUIDEWIRE: TRANSEND.; INTRODUCER SHEATH: 6FR MOSQUITO SHEATH.; INTRODUCER SHEATH: 6FR MOSQUITO SHEATH.