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 12/22/2020

Event Type  malfunction  

Manufacturer Narrative

(b)(6).

Event Description

It was reported that the balloon ruptured.The 100% stenosed target lesion area was located in a moderately tortuous and severely calcified below the knee artery.A 2.50mm/1.5cm/140cm small peripheral cutting balloon was selected for use.During the procedure, it was noted that the balloon ruptured at 10 atmospheres after being inflated once for 10 seconds.The device was removed using the normal method and the procedure was completed with another of the same device.There were no complications reported and the patient is 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 subjected to positive pressure.The returned device was attached to an encore inflation unit and positive pressure was applied, the balloon was inflated to its rate of burst pressure of 12 atmospheres for 30 seconds using digital timer: g24609, without issue.A vacuum was then applied.The inflation device was verified at 12 atmospheres, before and after.This inflation to rate of burst pressure of 12 atmospheres was repeated three times with no leaks or drop in pressure noted.No issues were identified with balloon inflation or the balloon material.The rated burst pressure for this device is 12 atmospheres.No issues were noted with the tip section of the device.A visual and microscopic examination found no issue with the markerbands.A visual and tactile examination found that the shaft was severely kinked at more than one location.This type of damage is consistent with excessive force being applied to the device.

Event Description

It was reported that the balloon ruptured.The 100% stenosed target lesion area was located in a moderately tortuous and severely calcified below the knee artery.A 2.50mm/1.5cm/140cm small peripheral cutting balloon was selected for use.During the procedure, it was noted that the balloon ruptured at 10 atmospheres after being inflated once for 10 seconds.The device was removed using the normal method and the procedure was completed with another of the same device.There were no complications reported and the patient is in good condition after the procedure.

• 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: 11073203
• MDR Text Key: 224312269
• Report Number: 2134265-2020-18459
• Device Sequence Number: 1
• Product Code: NWX
• Combination Product (y/n): N
• 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: 02/10/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/24/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 08/09/2021
• Device Model Number: 24658
• Device Catalogue Number: 24658
• Device Lot Number: 0022496595
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/18/2021
• Date Manufacturer Received: 02/03/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1