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

Model Number 24658

Device Problem Material Rupture (1546)

Patient Problems No Consequences Or Impact To Patient (2199); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 01/22/2021

Event Type  malfunction  

Manufacturer Narrative

(b)(6).

Event Description

It was reported that the balloon ruptured.The 95% stenosed target lesion area was located in a moderately tortuous and moderately calcified below the knee artery.A 2.00mm/1.5cm/140cm small peripheral cutting balloon was selected for use in a limb vasodilatation therapy.During the procedure, it was noted that the balloon ruptured at 12 atmospheres during the third inflation for 60 seconds.The device was removed with the usual method and the procedure was completed with a different device.There were no complications reported and the patient was in good condition after the procedure.

Event Description

It was reported that the balloon ruptured.The 95% stenosed target lesion area was located in a moderately tortuous and moderately calcified below the knee artery.A 2.00mm/1.5cm/140cm small peripheral cutting balloon was selected for use in a limb vasodilatation therapy.During the procedure, it was noted that the balloon ruptured at 12 atmospheres during the third inflation for 60 seconds.The device was removed with the usual method and the procedure was completed with a different device.There were no complications reported and the patient was in good condition after the procedure.

Manufacturer Narrative

E1.Initial reporter city: (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 investigator was unable to inflate the balloon due to the hypotube kinks and polymer extrusion kinks so the balloon rupture cannot be confirmed.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 multiple hypotube kinks and multiple polymer extrusion kinks.This type of damage is consistent with excessive force being applied when attempting to advance the device.No issues were noted with the markerbands.

• 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
• MDR Report Key: 11263298
• MDR Text Key: 229842368
• Report Number: 2134265-2021-01035
• Device Sequence Number: 1
• Product Code: NWX
• Combination Product (y/n): N
• PMA/PMN Number: P950020
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,distri
• Type of Report: Initial,Followup
• Report Date: 03/01/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 11/28/2022
• Device Model Number: 24658
• Device Catalogue Number: 24658
• Device Lot Number: 0024848966
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/11/2021
• Initial Date Manufacturer Received: 01/22/2021
• Initial Date FDA Received: 02/01/2021
• Supplement Dates Manufacturer Received: 02/24/2021
• Supplement Dates FDA Received: 03/01/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1