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

Model Number 24628

Device Problem Material Rupture (1546)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 12/16/2020

Event Type  malfunction  

Manufacturer Narrative

Initial reporter address: (b)(6).

Event Description

It was reported that the balloon ruptured and a pinhole noted.The 90% stenosed target lesion was located in the moderately tortuous and mildly calcified arteriovenous fistula in the forearm.A 5.00mm/ 2.0cm/ 50cm peripheral cutting balloon was selected for use.During procedure, it was noted that the balloon ruptured upon first inflation at 6atm.The device was simply pulled out from the patient's body and a pinhole was further noted.The procedure was completed with a different device.No patient complications were reported.

Event Description

It was reported that the balloon ruptured and a pinhole noted.The 90% stenosed target lesion was located in the moderately tortuous and mildly calcified arteriovenous fistula in the forearm.A 5.00mm/ 2.0cm/ 50cm peripheral cutting balloon was selected for use.During procedure, it was noted that the balloon ruptured upon first inflation at 6atm.The device was simply pulled out from the patient's body and a pinhole was further noted.The procedure was completed with a different device.No patient complications were reported.

Manufacturer Narrative

E1: initial reporter address 1 - (b)(6).Device evaluated by manufacturer: the device was returned for analysis.A visual examination identified that the balloon was not folded which indicates that the device was subjected to positive pressure.The returned device was attached to an encore inflation unit.Positive pressure was applied when liquid was observed to be leaking from a balloon pinhole located approximately 7mm proximal of the distal markerband.An examination of the balloon material and markerbands identified no issues which could potentially have contributed to this complaint.The rated burst pressure for this device is 10 atmospheres as per pcb2cm specification.A visual and microscopic examination observed no damage to the tip or blades.All blades were present and fully bonded to the balloon surface.A visual and tactile examination identified no kinks or damage to the shaft of the device.No other issues were identified during the product analysis.

• 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
• MDR Report Key: 11113430
• MDR Text Key: 225057060
• Report Number: 2134265-2020-18643
• Device Sequence Number: 1
• Product Code: LIT
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 01/22/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/04/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 06/19/2022
• Device Model Number: 24628
• Device Catalogue Number: 24628
• Device Lot Number: 0025620023
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/08/2021
• Date Manufacturer Received: 01/14/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: GUIDEWIRE - KYOUSHANT; GUIDEWIRE - KYOUSHANT; INTRODUCER SHEATH- 6FR; INTRODUCER SHEATH- 6FR