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 11/21/2023

Event Type  malfunction  

Event Description

It was reported that the catheter was stuck on the guidewire.A 4.0 x 200mm, 150cm ranger drug-coated balloon was selected for use.The stenosed target lesion was located in the mildly tortuous and moderately calcified popliteal artery.During the procedure, when the physician tried to advance the ranger over the guide wire, it got stuck into the shaft.The device was removed from the patient and the procedure was completed with another of the same device.There were no patient complications.

Manufacturer Narrative

Device evaluated by mfr: the complaint device was received for product analysis.The outer shaft, inner shaft, balloon and tip were visually and microscopically examined.Visual and microscopic examination revealed no damages.The device was tracked over a test 0.018" guidewire and it was able to pass through.Inspection of the remainder of the device presented no damage or irregularities.Product analysis could not confirm the reported froze on wire and found no damage that would have contributed to the reported event.

Event Description

It was reported that the catheter was stuck on the guidewire.A 4.0 x 200mm, 150cm ranger drug-coated balloon was selected for use.The stenosed target lesion was located in the mildly tortuous and moderately calcified popliteal artery.During the procedure, when the physician tried to advance the ranger over the guide wire, it got stuck into the shaft.The device was removed from the patient and the procedure was completed with another of the same device.There were no patient complications.

• 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: 18466495
• MDR Text Key: 332412604
• Report Number: 2124215-2023-74752
• Device Sequence Number: 1
• Product Code: ONU
• UDI-Device Identifier: 08714729975885
• UDI-Public: 08714729975885
• 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: 01/31/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/08/2024
• 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: 03885H23
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/02/2024
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/12/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/03/2023
• 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 Age: 67 YR
• Patient Weight: 73 KG