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); Stretched (1601)

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

Event Date 07/04/2022

Event Type  malfunction  

Event Description

It was reported that a shaft separation occurred.A 4.00mm/1.5cm/140cm small peripheral cutting balloon was selected for use.During preparation, the catheter was pulled out from the cloudy hoop, however resistance was felt when trying to remove the blue sheath mounted on the balloon.Consequently, the shaft stretched and separated when the device was pulled with force.The procedure was completed with another of the same device.There were no complications reported.

Manufacturer Narrative

Device evaluated by manufacturer: the device was returned for analysis.A visual examination identified a device separation of the shaft at the guidewire port.The distal section of the device including the shaft polymer extrusion, the balloon section, marker bands and tip was not returned with the device.The balloon protector was not returned with the device.A visual examination identified a device separation of the shaft at the guidewire port.The distal section of the device including the shaft polymer extrusion, the balloon section, marker bands and tip was not returned with the device.No issues were noted with the hypotube of the device.

Event Description

It was reported that a shaft separation occurred.A 4.00mm/1.5cm/140cm small peripheral cutting balloon was selected for use.During preparation, the catheter was pulled out from the cloudy hoop, however resistance was felt when trying to remove the blue sheath mounted on the balloon.Consequently, the shaft stretched and separated when the device was pulled with force.The procedure was completed with another of the same device.There were no complications 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: 15136822
• MDR Text Key: 297159229
• Report Number: 2124215-2022-27240
• Device Sequence Number: 1
• Product Code: NWX
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: P950020
• 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: 08/23/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/31/2022
• 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
• Date Returned to Manufacturer: 07/20/2022
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/04/2022
• 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