MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION SMALL PERIPHERAL CUTTING BALLOON; CATHETERS, TRANSLUMINAL CORONARY ANGIOPLASTY, PERCUTANEOUS

Model Number 24658

Device Problems Deflation Problem (1149); Difficult to Remove (1528); Material Rupture (1546)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 12/21/2021

Event Type  malfunction  

Event Description

It was reported that the balloon ruptured and could not be recovered within the sheath.The 99% stenosed target lesion was located in the moderately tortuous and moderately calcified superficial femoral artery.A 4.00mmx1.5cmx140cm small peripheral cutting balloon was selected for use.During the procedure, it was noted that the balloon ruptured upon first inflation at 4 atmospheres for about 2 seconds.It was not possible to deflate the balloon before it was removed outside the patient and it was unable to be recovered within the sheath, so the device was removed together with the sheath and the procedure was completed with a different device.There was no patient injury.

Event Description

It was reported that that the balloon ruptured and could not be recovered within the sheath.The 99% stenosed target lesion was located in the moderately tortuous and moderately calcified superficial femoral artery.A 4.00mmx1.5cmx140cm small peripheral cutting balloon was selected for use.During the procedure, it was noted that the balloon ruptured upon first inflation at 4 atmospheres for about 2 seconds.It was not possible to deflate the balloon before it was removed outside the patient and it was unable to be recovered within the sheath, so the device was removed together with the sheath and the procedure was completed with a different device.There was no patient injury.

Manufacturer Narrative

Device evaluated by mfr: the complaint device was received for product analysis.The device was received withdrawn into the customers 6fr sheath.For investigation purposes the investigator withdrew the device distally from the sheath to facilitate exposure of the balloon and shaft of the device.A visual examination identified that the balloon was not folded which indicates that the device was subjected to positive pressure.Blood was identified within the balloon which is evidence of a device leak.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 5mm distal of the proximal markerband.An examination of the balloon material and markerbands identified no issues which could potentially have contributed to this complaint.A visual and tactile examination found the shaft of the device to be kinked and stretched/damaged at more than one location.This type of damage is consistent with excessive tensile force being applied to the device.A visual and microscopic examination observed no damage to the tip or blades.All blades were present and fully bonded to the balloon surface.No issue was observed with the tip or markerbands of the device which could have contributed to the complaint incident.No other issues were identified during the product analysis.

• Brand Name: SMALL PERIPHERAL CUTTING BALLOON
• Type of Device: CATHETERS, TRANSLUMINAL CORONARY ANGIOPLASTY, PERCUTANEOUS
• 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: 13212851
• MDR Text Key: 283627105
• Report Number: 2134265-2022-00087
• Device Sequence Number: 1
• Product Code: NWX
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: P950020
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative,Distributor
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 02/23/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/10/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 07/21/2023
• Device Model Number: 24658
• Device Catalogue Number: 24658
• Device Lot Number: 0025745097
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/19/2022
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/31/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/21/2020
• 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
• Treatment: GUIDEWIRE - JUPITER; GUIDEWIRE - JUPITER; IMAGING CATHETER - TORQUE PORTER; IMAGING CATHETER - TORQUE PORTER; INFLATION DEVICE - NIPRO G30; INFLATION DEVICE - NIPRO G30; INTRODUCER SHEATH - IDEAL 6F; INTRODUCER SHEATH - IDEAL 6F