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

Model Number	1973-03
Medical Device Problem Codes	Material Rupture (1546); Failure to Deflate (4060)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/26/2023
Type of Reportable Event	Malfunction
Event or Problem 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 or Problem 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.
Additional 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
• Common Device Name: 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
• Report Number: 2124215-2023-41756
• Device Sequence Number: 5962329
• Product Code: ONU
• UDI-Device Identifier: 08714729976103
• UDI-Public: 08714729976103
• Combination Product (Y/N): Y
• Initial Reporter State: MN
• Initial Reporter Country: US
• PMA/510(K) Number: P190019
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 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
• Operator of Device: Health Professional
• Device Expiration Date: 09/29/2024
• 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
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 08/02/2023
• Supplement Date Received by Manufacturer: 08/24/2023
• Initial Report FDA Received Date: 08/07/2023
• Supplement Report FDA Received Date: 08/29/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/30/2022
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown