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

Model Number 24630

Device Problem Device-Device Incompatibility (2919)

Patient Problem Blood Loss (2597)

Event Date 03/06/2020

Event Type  Injury  

Event Description

It was reported that blades of the cutting balloon cut the patient during removal. The 99% stenosed target lesion was located in the moderately tortuous and moderately calcified left external iliac artery. A 6. 00mm/2. 0cm/90cm peripheral cutting balloon was selected for use. During the procedure, pre dilation was performed using a 3mm-20mm and 5mm-40mm after the guidewire was crossed and then this device was used. The balloon position was slightly shifted at 6atm for about 30 seconds on the first time, and the vessel was dilated three times at about 6atm to 8atm for about 30 seconds. Inflation and deflation were performed slowly, however the blade protruded from the sheath upon removal and bleeding was noted. As per physician, the blade cut the skin at the puncture sit which made the site expanded. The procedure was completed with a different device. There were no patient complications reported.

• 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 IRELAND LIMITED; ballybrit business park; galway ; EI
• Manufacturer Contact: jay johnson ; two scimed place; maple grove, MN 55311 ; 7634942574
• MDR Report Key: 9888381
• MDR Text Key: 187708376
• Report Number: 2134265-2020-03967
• Device Sequence Number: 1
• Product Code: LIT
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K070951
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,distri

Reporter Occupation

• Type of Report: Initial,Followup,Followup
• Report Date: 06/24/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/27/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes

Device Operator

• Device Expiration Date: 09/22/2021
• Device Model Number: 24630
• Device Catalogue Number: 24630
• Device Lot Number: 0024476257
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/23/2020
• Is the Reporter a Health Professional?: Yes

Was the Report Sent to FDA?

• Event Location: No Information
• Date Manufacturer Received: 06/11/2020
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/23/2019
• 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: 03/27/2020 Patient Sequence Number: 1