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

Model Number 24658

Device Problem Detachment of Device or Device Component (2907)

Patient Problem No Code Available (3191)

Event Date 07/10/2020

Event Type  Injury  

Manufacturer Narrative

Initial reporter city: (b)(6).

Event Description

It was reported that the blade penetrated in the vascular tissue and separated from the balloon.The 75% stenosed target lesion was located in a straight shunt vessel.A 4.00mm/1.5cm/140cm small peripheral cutting balloon was selected for use.Dilation was performed several times using this device and was removed from the patient's body.Post procedure, foreign object was found in the area where dilation was performed when echo was done.Subsequently, foreign object was grasped using biopsy forceps, and was removed outside the body successfully.It was then confirmed to be the blade of this device.There were no remnants inside the body, and there was no adverse health hazard to the patient.It was suspected that the blade penetrated the vascular tissue and got separated from the balloon.The procedure was completed with this device.There were no remnants inside the body, and there was no adverse health hazard to the patient.

• 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 ; two scimed place; maple grove, MN 55311 ; 7634942574
• MDR Report Key: 10349926
• MDR Text Key: 201732207
• Report Number: 2134265-2020-10208
• 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: company representative,distri
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 07/31/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 12/15/2022
• Device Model Number: 24658
• Device Catalogue Number: 24658
• Device Lot Number: 0024936741
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 07/10/2020
• Initial Date FDA Received: 07/31/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 12/16/2019
• 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
• Patient Outcome(s): Required Intervention