MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION 2CM PERIPHERAL CUTTING BALLOON CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINA

Model Number 24630

Device Problems Deflation Problem (1149); Difficult to Remove (1528); Material Integrity Problem (2978)

Patient Problem Hemorrhage/Bleeding (1888)

Event Date 03/18/2021

Event Type  Injury  

Event Description

It was reported that the balloon would not deflate and was manually burst in order to remove the device from the patient. An 8mm, 2cm peripheral cutting balloon was selected for use in an upper arm fistuloplasty procedure. During the procedure, two structures were successfully treated with the balloon. After the last inflation, the balloon would not fully deflate. Contrast was seen in the balloon. The balloon was partially inflated again to see if it would deflate. An empty 20ml syringe was used to pull back negative pressure, but this did not empty all the contrast. The balloon was punctured with a needle through the flesh in order to deflate and remove the balloon from the patient. This was partially successful, but there was still contrast in the balloon. Repeated attempts were made to pull the partially deflated balloon back into the 7f 11cm super sheath, but these attempts failed. The physician believes this caused damage to the shaft of the balloon which could be seen upon removal. The sheath and the partially inflated balloon were removed together, which involved dragging the balloon and sheath out together. This resulted in a ragged exit hole in the upper arm that required stitches followed by 10 minutes of pushing to achieve stasis. After this and while still in recovery, the exit wound opened, and the patient bled out approximately 250mls of blood. A further 30 minutes of pressure was applied to the exit wound, and this stopped the flow of blood. Due to these events, the patient was admitted to a ward bed for observation and is to be reviewed by surgeons. The patient has not yet had surgery but may need reconstructive fistula surgery.

• Brand Name: 2CM PERIPHERAL CUTTING BALLOON
• Type of Device: CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINA
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; two scimed place; maple grove MN 55311
• Manufacturer (Section G): BOSTON SCIENTIFIC CORPORATION; ballybrit business park; galway ; EI
• Manufacturer Contact: jay johnson ; two scimed place; maple grove, MN 55311 ; 7634942574
• MDR Report Key: 11561833
• MDR Text Key: 241999425
• Report Number: 2134265-2021-03783
• Device Sequence Number: 1
• Product Code: LIT
• Combination Product (y/n): N
• Reporter Country Code: UK
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig

Reporter Occupation

• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 09/12/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/24/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes

Device Operator

• Device Model Number: 24630
• Device Catalogue Number: 24630
• Device Lot Number: 0026527485
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/31/2021
• Is the Reporter a Health Professional?: Yes

Was the Report Sent to FDA?

• Event Location: No Information
• Date Manufacturer Received: 08/20/2021
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/16/2020
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial

Patient Treatment Data

Date Received: 03/24/2021 Patient Sequence Number: 1