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

Model Number 1973-03

Device Problems Device Dislodged or Dislocated (2923); Manufacturing, Packaging or Shipping Problem (2975)

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

Event Date 02/14/2022

Event Type  malfunction  

Manufacturer Narrative

Initial reporter facility name: (b)(6) hospital.Initial reporter city:(b)(6).

Event Description

It was reported that the drug coating on the balloon had fallen off.A 5.0 x 200mm, 150cm ranger paclitaxel-coated pta balloon catheter was selected for use in the superficial femoral artery.When the balloon was opened, the loading tool was noted to have shifted at the tip side of the balloon.The physician pulled the loading tool toward the shaft to pass the wire, but it did not move.When it was moved in the opposite direction, the loading tool came off and the drug coating had fallen off.The use of the device was discontinued and the procedure was completed with another of the same device.There were no patient complications reported.

• Brand Name: RANGER PACLITAXEL-COATED PTA BALLOON CATHETER
• Type of Device: DRUG-ELUTING PERIPHERAL TRANSLUMINAL ANGIOPLASTY CATHETER
• 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: 13733305
• MDR Text Key: 287021518
• Report Number: 2134265-2022-02492
• Device Sequence Number: 1
• Product Code: ONU
• UDI-Device Identifier: 08714729976042
• UDI-Public: 08714729976042
• Combination Product (y/n): Y
• Reporter Country Code: JA
• PMA/PMN Number: P190019
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative,Distributor
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 03/11/2022

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 Expiration Date: 07/14/2023
• Device Model Number: 1973-03
• Device Catalogue Number: 1973-03
• Device Lot Number: 04461H21
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 02/15/2022
• Initial Date FDA Received: 03/11/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/14/2021
• 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