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

Model Number 1177-01

Device Problems Deflation Problem (1149); Detachment of Device or Device Component (2907)

Patient Problem Foreign Body In Patient (2687)

Event Date 06/21/2021

Event Type  Injury  

Event Description

It was reported the balloon failed to deflate and a portion was left in the patient.A ranger 7.0 mm x 40 mm, 80 cm over the wire (otw) drug coated balloon (dcb) was being used for an avf angioplasty procedure.The ranger balloon 7x40mm was used to dilate the previously stented vessel at 14atm and deflated successfully.Then a mustang 8x40mm was used to post dilate the vessels.The physician decided to reuse the ranger 7x40mm balloon.After inflating the ranger balloon 3 more times, the balloon was unable to deflate despite 2 to 4 attempts.The physician used a micro-puncture needle to prick the balloon externally to remove the ranger balloon from the vessel, but 1/3 of the balloon was missing.A computed tomography (ct) and ct pulmonary angiogram (ctpa) scan were performed but the missing piece was not found.The physician believed that it's too small to be detected and does not cause harm to the patient as she is stable.The sheath and balloon hub were dissected to check for the remnant but nothing was found.Facility staff measured the balloon with a brand new 40mm ranger balloon, and only 2-3mm was missing.Follow up with surgeon 1-day post-op, patient is well and stable.

• Brand Name: RANGER
• Type of Device: CATHETER, PERCUTANEOUS
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; two scimed place; maple grove MN 55311
• Manufacturer (Section G): HEMOTEQ AG; adenauerstrasse 15; wuerselen 52146 ; GM 52146
• Manufacturer Contact: jay johnson ; two scimed place; maple grove, MN 55311 ; 7634942574
• MDR Report Key: 12143184
• MDR Text Key: 260720586
• Report Number: 2134265-2021-08193
• Device Sequence Number: 1
• Product Code: ONU
• Combination Product (y/n): Y
• Reporter Country Code: SN
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 07/09/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/09/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 01/28/2023
• Device Model Number: 1177-01
• Device Catalogue Number: 1177-01
• Device Lot Number: 00833H21
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 06/21/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/28/2021
• 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
• Patient Outcome(s): Other