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

Model Number 24658

Device Problem Inflation Problem (1310)

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

Event Date 01/15/2021

Event Type  malfunction  

Manufacturer Narrative

(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 balloon was subjected to positive pressure.A longitudinal tear was identified in the balloon material.The tear measured 14 mm in length and extended from a position 1mm distal of the proximal markerband to 4mm proximal of the distal markerband.An examination of the balloon material and markerbands identified no issues which could potentially have contributed to this complaint.A visual and microscopic examination observed no damage to the tip or blades of the device.A visual and tactile examination found no kinks or damage to the hypotube of the device.Both markerbands were undamaged and present on the hypotube of the device.No other issues were identified during the product analysis.

Event Description

Reportable based on device analysis completed on 19feb2021.It was reported that the device failed to inflate.The 90% stenosed target lesion area was located in a moderately tortuous and moderately calcified superficial femoral artery.A 4.00mm/1.5cm/140cm small peripheral cutting balloon was selected for use in a endoscopic third ventriculostomy (evt).During the procedure, it was noted that the device failed to inflate.The procedure was completed with another of the same device.There were no patient complications reported.However, device analysis revealed a longitudinal tear measured 14 mm in length and extended from a position 1mm distal of the proximal markerband to 4mm proximal of the distal markerband.

• 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: 11394598
• MDR Text Key: 234089180
• Report Number: 2134265-2021-02451
• 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: company representative,distri
• Reporter Occupation: Physician
• Type of Report: Initial
• 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: 04/20/2023
• Device Model Number: 24658
• Device Catalogue Number: 24658
• Device Lot Number: 0025453834
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/11/2021
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 02/19/2021
• Initial Date FDA Received: 03/01/2021
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/20/2020
• 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