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 Manufacturing, Packaging or Shipping Problem (2975); Material Integrity Problem (2978)

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

Event Date 12/28/2021

Event Type  malfunction  

Event Description

It was reported that the coating fell out.The target lesion was located in the superficial femoral artery (sfa).A 5.0 x 200mm, 150cm ranger paclitaxel-coated pta balloon catheter was selected for use.Upon opening the device, the balloon inflated when it was connected to the indeflator.Although it was only a slight inflation, it was not used as the physician testified that the paclitaxel coating fell out.There was no physical damage noted to the balloon.It was reported that air may have remained in the indeflator.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; 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: 13367543
• MDR Text Key: 284540872
• Report Number: 2134265-2022-00774
• 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: 01/27/2022

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: 08/20/2023
• Device Model Number: 1973-03
• Device Catalogue Number: 1973-03
• Device Lot Number: 05609H21
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 12/28/2021
• Initial Date FDA Received: 01/27/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/20/2021
• 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