MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION RANGER; CATHETER, PERCUTANEOUS

Model Number 26102

Device Problems Deflation Problem (1149); Difficult to Remove (1528); Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems No Code Available (3191); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 12/07/2020

Event Type  Injury  

Event Description

It was reported that failure to deflate and remove a balloon, and additional intervention occurred.An iliac angioplasty was performed on a common femoral artery (cfa).A 8.0 mm x 40mm, 80 cm ranger (dcb) balloon was advanced and inflated for three minutes to dilate the lesion.While attempting to deflate and remove the balloon through the sheath, the balloon would not fully deflate and could therefore not be removed through the sheath.It was noted that there were multiple attempts to deflate and inflate the balloon without success.The balloon was brought back as close as possible to the exit point of the cfa, where the balloon was then punctured with a percutaneous access needle, which facilitated the removal of the device through the sheath.The procedure was completed and no patient complications resulted in relation to this event.

Manufacturer Narrative

Device evaluated by mfr:the returned product consisted of a ranger (dcb) balloon catheter.The shaft, hypotube, tip and balloon were microscopically and visually examined.There was a pinhole at the distal marker band.There was no marker band damage detected.The inner shaft was separated 77.8cm from the strain relief.The outer shaft was stretched down starting 51.5cm from the strain relief and extending to the proximal end of the balloon.The balloon was prolapsed.Inspection of the remainder of the device presented no other damage or irregularities.

Event Description

It was reported that failure to deflate and removal difficulties occurred.An iliac angioplasty was performed on a common femoral artery (cfa).A 8.0 mm x 40mm, 80 cm ranger (dcb) balloon was advanced and inflated for three minutes to dilate the lesion.While attempting to deflate and remove the balloon through the sheath, the balloon would not fully deflate and could therefore not be removed through the sheath.It was noted that there were multiple attempts to deflate and inflate the balloon without success.The balloon was brought back as close as possible to the exit point of the cfa, where the balloon was then punctured with a percutaneous access needle, which facilitated the removal of the device through the sheath.The procedure was completed and no patient complications resulted in relation to this event.

• Brand Name: RANGER
• Type of Device: CATHETER, PERCUTANEOUS
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; two scimed place; maple grove MN 55311
• MDR Report Key: 11119438
• MDR Text Key: 225246546
• Report Number: 2134265-2021-00015
• Device Sequence Number: 1
• Product Code: DQY
• 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: 03/22/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 03/23/2022
• Device Model Number: 26102
• Device Catalogue Number: 26102
• Device Lot Number: 02413H20
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/18/2021
• Initial Date Manufacturer Received: 12/07/2020
• Initial Date FDA Received: 01/05/2021
• Supplement Dates Manufacturer Received: 03/18/2021
• Supplement Dates FDA Received: 03/22/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention