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 Code	Material Rupture (1546)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/01/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that balloon rupture occurred.A 4.0 x 40mm, 135cm ranger drug coated balloon was advanced for dilatation.However, during the procedure, the balloon had a hole, preventing it from inflating properly.There were no patient complications reported.
Additional Manufacturer Narrative
B3: event date: used the first date of the month of the aware date as no event date was provided.
Additional Manufacturer Narrative
B3: event date: used the first date of the month of the aware date as no event date was provided.
Event or Problem Description
It was reported that balloon rupture occurred.A 4.0 x 40mm, 135cm ranger drug coated balloon was advanced for dilatation.However, during the procedure, the balloon had a hoe, preventing it from inflating properly.There were no patient complications reported.It was further reported that the broken balloon wasn't even used on the patient.When they opened the package, they saw there was a big hole in the balloon.
Additional Manufacturer Narrative
B3: event date: used the first date of the month of the aware date as no event date was provided.
Event or Problem Description
It was reported that balloon rupture occurred.A 4.0 x 40mm, 135cm ranger drug coated balloon was advanced for dilatation.However, during the procedure, the balloon had a hole, preventing it from inflating properly.There were no patient complications reported.It was further reported that the broken balloon wasn't even used on the patient.When they opened the package, they saw there was a big hole in the balloon.It was further reported that the general geometry of the target vessel is the simple superficial femoral artery.

• 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): BOSTON SCIENTIFIC CORPORATION; maple grove MN 55311
• Manufacturer Contact: rachel shields ; 4100 hamline ave n; arden hills, MN 55112 ; 6512422111
• MDR Report Key: 18825364
• Report Number: 2124215-2024-12297
• Device Sequence Number: 12709139
• Product Code: ONU
• UDI-Device Identifier: 08714729975762
• UDI-Public: 08714729975762
• Combination Product (Y/N): Y
• Initial Reporter State: VA
• 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: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 05/07/2024

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 Model Number: 1973-03
• Device Catalogue Number: 1973-03
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 02/15/2024
• Supplement Date Received by Manufacturer: 02/29/2024; 04/24/2024
• Initial Report FDA Received Date: 03/04/2024
• Supplement Report FDA Received Date: 03/14/2024; 05/07/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown