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

Model Number 24628

Device Problems Material Rupture (1546); Detachment of Device or Device Component (2907)

Patient Problem Hemorrhage/Bleeding (1888)

Event Date 11/25/2021

Event Type  Injury  

Manufacturer Narrative

(b)(6).

Event Description

It was reported that blade separation, balloon rupture and bleeding occurred. The 75% stenosed target lesion was located in the moderately tortuous and non-calcified antebrachium. A 5. 00mm/2. 0cm/50cm peripheral cutting balloon was selected for use. During the procedure, five of the antebrachium sites were dilated from distal to nominal. However, it was not fully dilated, therefore, it was dilated at 10atm. The remaining three sites were dilated at 10atm, however it was noted that the balloon ruptured at 4atm in the proximal lesion. A blade separation was confirmed via echo. The blade fragment was confirmed near the sheath. Another 6fr sheath was placed on the peripheral side, and biopsy forceps were used to catch and recover it in the sheath under echo. The sheath was pulled out and bleeding has stopped. All the blades have been removed and no fragment remains inside the patient. The procedure was completed with the original device. No further patient complications were 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: 13172935
• MDR Text Key: 283296151
• Report Number: 2134265-2021-16261
• 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: Foreign,Health Professional,Company Representative,Distributor

Reporter Occupation

• Type of Report: Initial,Followup
• Report Date: 02/16/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/05/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes

Device Operator

• Device Model Number: 24628
• Device Catalogue Number: 24628
• Device Lot Number: 0027783158
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/17/2022
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/26/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/05/2021
• 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: 01/05/2022 Patient Sequence Number: 1

Treatment

GUIDEWIRE: TERUMO RADIFOCUS; INTRODUCER SHEATH: MEDIKIT ULTRA HIGH FLOW