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

Model Number 24628

Device Problems Leak/Splash (1354); Material Rupture (1546)

Patient Problems Extravasation (1842); No Consequences Or Impact To Patient (2199)

Event Date 03/23/2020

Event Type  Injury  

Manufacturer Narrative

(b)(6).

Event Description

It was reported that a balloon rupture occurred. The 75% stenosed target lesion was located in the moderately tortuous forearm. A 5. 00mm / 2. 0cm / 50cm peripheral cutting balloon was selected for use in a shunt percutaneous transluminal angioplasty. During procedure, at fourth inflation, the balloon ruptured at 3 atm for 90 seconds. However, it was noted that the rupture of the blood vessel was confirmed at the same time as the rupture of the balloon. This device was inflated 4 times and was inflated three times at area different from the area where vascular rupture occurred. Subsequently, the blood vessel ruptured in one dilation and was not sure as to occurred first, rupture of the balloon or the rupture of the blood vessel. However, it was further reported that there was no perforation occurred. Then, the physician tried to stop bleeding from inside the blood vessel with a balloon, but the bleeding could not be stopped, so the physician surgically stopped the bleeding. There were no resistance and abnormalities noted. The procedure was not resolved. No patient complications reported. The patient was stable after the procedure.

• 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: 9923594
• MDR Text Key: 186549044
• Report Number: 2134265-2020-04377
• Device Sequence Number: 1
• Product Code: LIT
• Combination Product (y/n): N
• Reporter Country Code: JA
• 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
• Report Date: 04/09/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/03/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes

Device Operator

• Device Expiration Date: 11/17/2021
• Device Model Number: 24628
• Device Catalogue Number: 24628
• Device Lot Number: 0024784245
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes

Was the Report Sent to FDA?

• Event Location: No Information
• Date Manufacturer Received: 03/23/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 11/18/2019
• 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: 04/03/2020 Patient Sequence Number: 1