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

Model Number 1177-01

Device Problems Deflation Problem (1149); Difficult to Remove (1528); Detachment of Device or Device Component (2907)

Patient Problem Foreign Body In Patient (2687)

Event Date 06/01/2022

Event Type  Injury  

Event Description

It was reported that the balloon failed to deflate and detached.Vascular access was gained via ipsilateral antegrade using ultrasound scan (uss) and ii-guided access.The target lesion was located in the common femoral artery (cfa).A 4x200mm, 150cm ranger balloon was selected an angioplasty procedure to treat critical limb ishemia.The balloon was inflated once to the maximum recommended pressure.The physician pressed the inflator button to deflate the balloon and the balloon initially appeared to be deflated; however, the balloon was partially inflated and was difficult to remove from the non-boston scientific 5f sheath.It was noted that the vacuum was removed during withdrawal.The balloon was pulled harder and got stuck in the sheath with a section of the balloon outside of the body and the remainder of the balloon was still within the patient.The balloon was pulled until it came out of the patient.It was then noticed that a 10mm segment of the balloon was missing.The missing balloon segment was unable to be located using x-ray imaging, and both duplex and ct angiogram.The procedure was partially completed as the physician was unable to do any completion angios since the sheath had to be removed.No further action was taken.There were no patient complications and the patients status was perfect post procedure.

Manufacturer Narrative

Initial reporter phone: (b)(6).

• 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: 14806656
• MDR Text Key: 295027255
• Report Number: 2134265-2022-06492
• Device Sequence Number: 1
• Product Code: ONU
• Combination Product (y/n): Y
• Reporter Country Code: EI
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 06/24/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/24/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 07/25/2023
• Device Model Number: 1177-01
• Device Catalogue Number: 1177-01
• Device Lot Number: 00788H22
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 06/02/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/24/2022
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other