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

Model Number 24658

Device Problems Break (1069); Difficult to Remove (1528)

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

Event Date 08/17/2022

Event Type  malfunction  

Event Description

It was reported that a shaft separation occurred.The 90% stenosed target lesion was located in the moderately tortuous and moderately calcified vessel.A 4.00mm/1.5cm/140cm small peripheral cutting balloon was selected for use.During the procedure, outside the patient's body, it was noted that there was severe resistance when the blue cap was removed.The balloon was pulled as it was and it was noted that the shaft got separated.The procedure was completed with another of same device.No patient complications were reported.

Manufacturer Narrative

Device evaluated by mfr: the device was returned for evaluation.The device was returned with the balloon completely detached from the device.The balloon material was detached at the proximal balloon sleeve.The balloon material including all blades, a section of shaft and the tip of the device were not returned for analysis.This type of damage is consistent with excessive tensile force being applied to the device.A visual and tactile examination found the shaft polymer extrusion to be completely detached at approximately 5mm distal of the distal markerband.The balloon material including all blades, a section of shaft and the tip of the device were not returned for analysis.This type of damage is consistent with excessive tensile force being applied to the device.The shaft was also found to be kinked at more than one location.The device was received with the balloon protector removed.The balloon protector was not returned for analysis.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.

Event Description

It was reported that a shaft separation occurred.The 90% stenosed target lesion was located in the moderately tortuous and moderately calcified vessel.A 4.00mm/1.5cm/140cm small peripheral cutting balloon was selected for use.During the course of the procedure, outside the patient's body, it was noted that there was severe resistance when the blue cap was removed.The balloon was pulled as it was and it was noted that the shaft got separated.The procedure was completed with another of the same device.No patient complications were reported.

• 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: 15387651
• MDR Text Key: 303742363
• Report Number: 2124215-2022-34244
• 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: 10/06/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/08/2022
• 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
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 09/14/2022
• 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