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

Model Number 24628

Device Problem Inflation Problem (1310)

Patient Problems Hemorrhage/Bleeding (1888); Thrombosis (2100); Stenosis (2263)

Event Date 07/21/2020

Event Type  Injury  

Event Description

It was reported that bleeding and vessel damage occurred.The 99% stenosed target lesion area was located in a mildly tortuous and mildly calcified forearm vein.A 5.00mm / 2.0cm / 50cm peripheral cutting balloon (pcb) and bravus balloon dilatation catheter were selected for vascular access intervention therapy.During the procedure, the bravus balloon dilatation catheter had balloon inflation failure.The peripheral cutting balloon was used and also had inflation failure.Inflation failure and bleeding was confirmed when the pcb was inflated at 10 atm.The amount of bleeding was unknown, the physician noted that the bleeding was likely vessel damage.The bleeding was arrested by pcb inflation at 2 atm.The procedure was completed after hemostasis was confirmed with a different device.On july 28th, occlusion was seen.Although hemostasis was performed, thrombus was in place on where the balloon was inflated.The patient was scheduled for an intervention.

• 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: 10385865
• MDR Text Key: 202253574
• Report Number: 2134265-2020-10723
• 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,foreig
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 08/10/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/10/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 24628
• Device Catalogue Number: 24628
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 07/21/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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): Other