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	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	07/05/2021
Type of Reportable Event	Death
Additional Manufacturer Narrative
Patient identifier : (b)(6).
Event or Problem Description
It was reported the subject died.On (b)(6) 2021 , the subject underwent treatment with a 4.0 x 80mm, 135cm ranger drug coated balloon.The target lesion was 80 mm long, located in the left proximal popliteal artery and mid popliteal artery.Post dilatation was performed using a sterling otw, 5 mm x 80 mm as an adjunctive device to treat the target lesion, residual stenosis was unknown.On (b)(6) 2021, 17 days post-index procedure, it was reported the subject expired in an outlying hospital.A death certificate is not available, and it is unknown whether an autopsy was performed or not.

• Brand Name: RANGER PACLITAXEL-COATED PTA BALLOON CATHETER
• Common Device Name: DRUG-ELUTING PERIPHERAL TRANSLUMINAL ANGIOPLASTY CATHETER
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; two scimed place; maple grove MN 55311
• MDR Report Key: 12492492
• Report Number: 2134265-2021-11754
• Device Sequence Number: 19854240
• Product Code: ONU
• UDI-Device Identifier: 08714729975809
• UDI-Public: 08714729975809
• Combination Product (Y/N): Y
• Initial Reporter State: IL
• 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: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 09/17/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Expiration Date: 08/29/2022
• Device Model Number: 1973-03
• Device Catalogue Number: 1973-03
• Device Lot Number: 01746H21
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 08/26/2021
• Initial Report FDA Received Date: 09/17/2021
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Death
• Patient Age: 78 YR