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

Model Number H74939670500610

Device Problem Device Difficult to Setup or Prepare (1487)

Patient Problem Foreign Body In Patient (2687)

Event Date 04/28/2023

Event Type  Injury  

Manufacturer Narrative

D4, h4: lot number is unknown; therefore, the manufacture date and expiration date are unknown.

Event Description

It was reported that the loading tool might have accidently been left on the balloon when it entered into the patient.This ranger drug-coated balloon 5.0 mm x 60 mm, 160 cm was selected for use during this lower extremity angiogram with intervention to treat peripheral arterial disease.Discussion with the physician during the procedure indicated that the loading tool might have accidently been left on the balloon when it entered into the patient.When inflating the balloon, it was observed that only the proximal portion of the balloon was inflating.Upon removing the balloon from the sheath, no introducer was noted on the catheter or body of the balloon.Multiple attempts were made to diagnostically determine if the loading tool was in the patient.Internal ultrasound, external ultrasound, and angiography were all performed, but were inconclusive.The loading tool was also nowhere to be found on the sterile field.The physician noted there to be a little bit of resistance in the proximal sfa portion, just beyond where the sheath ended.He consulted with colleagues and determined the best choice for the patient was to deploy a stent where the area in question was in effort to trap it in place, should there be anything remnant there.The physician was planning to stent in that area prior to this event happening.The physician will continue to monitor the patient for any potential adverse effects from this incident, however there were no reports of patient complications at this time of this report.

• Brand Name: RANGER
• Type of Device: CATHETER, PERCUTANEOUS
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 300 boston scientific way; marlborough MA 01752
• Manufacturer (Section G): HEMOTEQ AG; adenauerstrasse 15; wuerselen 52146 ; GM 52146
• Manufacturer Contact: jeff wallner ; 4100 hamline ave n; arden hills, MN 55112 ; 6515811560
• MDR Report Key: 17001673
• MDR Text Key: 315919322
• Report Number: 2124215-2023-26046
• Device Sequence Number: 1
• Product Code: ONU
• Combination Product (y/n): Y
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 05/25/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/25/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: H74939670500610
• Device Catalogue Number: H74939670500610
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/28/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention