MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION RANGER PACLITAXEL-COATED PTA BALLOON CATHETER; DRUG-ELUTING PERIPHERAL TRANSLUMINAL ANGIOPLASTY CATHETER

Model Number 1973-03

Device Problem Entrapment of Device (1212)

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

Event Date 10/31/2023

Event Type  malfunction  

Event Description

It was reported that the ranger froze on the guidewire.A ranger paclitaxel-coated pta balloon catheter was selected for use in an angioplasty procedure.A v-18 controlwire was placed without issue.When the physician attempted to advance the ranger delivery system over the v-18, the ranger became stuck and would not advance any further once the balloon began to track over the wire.The ranger device was exchanged in order to complete the procedure.The procedure was completed, and there were no reported consequences to the patient.

Manufacturer Narrative

Device analysis: returned product consisted of a ranger drug coated balloon catheter.The outer shaft, inner shaft, balloon, and tip were visually and microscopically examined.Visual examination revealed buckling to the guidewire lumen 19.5cm from the tip.Microscopic and visual inspection of the remainder of the device presented no other damage or irregularities.Product analysis found damage that would have contributed to the reported event.

Event Description

It was reported that the ranger froze on the guidewire.A ranger paclitaxel-coated pta balloon catheter was selected for use in an angioplasty procedure.A v-18 controlwire was placed without issue.When the physician attempted to advance the ranger delivery system over the v-18, the ranger became stuck and would not advance any further once the balloon began to track over the wire.The ranger device was exchanged in order to complete the procedure.The procedure was completed, and there were no reported consequences to the patient.

• Brand Name: RANGER PACLITAXEL-COATED PTA BALLOON CATHETER
• Type of Device: DRUG-ELUTING PERIPHERAL TRANSLUMINAL ANGIOPLASTY CATHETER
• 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: 18191928
• MDR Text Key: 328803905
• Report Number: 2124215-2023-65500
• Device Sequence Number: 1
• Product Code: ONU
• UDI-Device Identifier: 08714729976042
• UDI-Public: 08714729976042
• Combination Product (y/n): Y
• PMA/PMN Number: P190019
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 12/15/2023

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: 1973-03
• Device Catalogue Number: 1973-03
• Device Lot Number: 01426H23
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/15/2023
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 11/01/2023
• Initial Date FDA Received: 11/22/2023
• Supplement Dates Manufacturer Received: 11/29/2023
• Supplement Dates FDA Received: 12/15/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/01/2023
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Treatment: V-18 CONTROLWIRE; V-18 CONTROLWIRE
• Patient Age: 66 YR
• Patient Sex: Female
• Patient Weight: 68 KG