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

Model Number 1177-01

Device Problems Entrapment of Device (1212); Adverse Event Without Identified Device or Use Problem (2993)

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

Event Date 07/05/2023

Event Type  malfunction  

Event Description

It was reported that the balloon catheter became entrapped on the guidewire.A v-18 control wire and 8.0 mm x 80 mm, 135 cm ranger balloon were selected for use in a percutaneous transluminal angioplasty procedure.The balloon was unable to be advanced on the guidewire; therefore, the balloon never entered the patient.The guidewire and balloon were removed together, and the procedure was completed using a new guidewire and new ranger balloon.There were no patient complications.

Manufacturer Narrative

E1, initial reporter phone: (b)(6).Device eval by manufacturer: upon receipt at our post market quality assurance laboratory, this ranger balloon catheter was visually and microscopically examined.Visual examination revealed that the inflation lumen and guidewire lumen was separated 129.6cm from the hub.The end of the separation appeared to have been stretched prior to separating.There was buckling to the inflation lumen 10cm from the tip and buckling to the guidewire lumen 7mm from the tip.Microscopic examination revealed damage to the tip.Inspection of the remainder of the device presented no other damage or irregularities.Product analysis found damage that would have contributed to the froze on wire.

Event Description

It was reported that the balloon catheter became entrapped on the guidewire.A v-18 control wire and 8.0 mm x 80 mm, 135 cm ranger balloon were selected for use in a percutaneous transluminal angioplasty procedure.The balloon was unable to be advanced on the guidewire; therefore, the balloon never entered the patient.The guidewire and balloon were removed together, and the procedure was completed using a new guidewire and new ranger balloon.There were no patient complications.

• 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: rachel shields ; 4100 hamline ave n; arden hills, MN 55112 ; 6512422111
• MDR Report Key: 17396519
• MDR Text Key: 319935277
• Report Number: 2124215-2023-39576
• Device Sequence Number: 1
• Product Code: ONU
• Combination Product (y/n): Y
• Reporter Country Code: UK
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Health Professional,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 10/17/2023

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 Model Number: 1177-01
• Device Catalogue Number: 1177-01
• Device Lot Number: 02059H23
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 07/25/2023
• Initial Date FDA Received: 07/26/2023
• Supplement Dates Manufacturer Received: 10/10/2023
• Supplement Dates FDA Received: 10/17/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/03/2023
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Treatment: V-18 GUIDEWIRE; V-18 GUIDEWIRE