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 Material Rupture (1546); Failure to Deflate (4060)

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

Event Date 06/26/2023

Event Type  malfunction  

Event Description

It was reported that the balloon would not deflate, then was believed to have broken.This 6.0 x 60mm, 135cm ranger paclitaxel-coated pta balloon catheter was selected for use in a vascular intervention procedure for peripheral artery disease.This device was inflated for three minutes during the procedure.Several different attempts were made to deflate the balloon for several minutes without success.Then it was believed that the balloon may have broken, and the balloon was able to be pulled back into the sheath and out of the patient.The procedure was completed and there were no patient complications.

Event Description

It was reported that the balloon would not deflate, then was believed to have broken.This 6.0 x 60mm, 135cm ranger paclitaxel-coated pta balloon catheter was selected for use in a vascular intervention procedure for peripheral artery disease.This device was inflated for three minutes during the procedure.Several different attempts were made to deflate the balloon for several minutes without success.Then it was believed that the balloon may have broken, and the balloon was able to be pulled back into the sheath and out of the patient.The procedure was completed and there were no patient complications.

Manufacturer Narrative

Device eval by manufacturer: upon receipt at our post market quality assurance laboratory,this 6.0 x 60mm, 135cm ranger paclitaxel-coated pta balloon catheter was visually and microscopically examined.Visual examination revealed multiple stretched sections along the inflation lumen.Microscopic examination revealed no additional damages.Functional testing was attempted but the damage prevented inflation testing.Inspection of the remainder of the device presented no other damage or irregularities.Product analysis found damage that would have contributed to the failure to deflate but could not confirm the rupture.

• 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: 17469611
• MDR Text Key: 320879105
• Report Number: 2124215-2023-41756
• Device Sequence Number: 1
• Product Code: ONU
• UDI-Device Identifier: 08714729976103
• UDI-Public: 08714729976103
• Combination Product (y/n): Y
• Reporter Country Code: US
• PMA/PMN Number: P190019
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 08/29/2023

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: 08121H22
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 08/02/2023
• Initial Date FDA Received: 08/07/2023
• Supplement Dates Manufacturer Received: 08/24/2023
• Supplement Dates FDA Received: 08/29/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/30/2022
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1