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

Model Number 1973-01

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Vascular Dissection (3160)

Event Date 11/16/2017

Event Type  Injury  

Event Description

Ranger ii sfa.It was reported that a dissection occurred.The subject was enrolled into ranger ii sfa study on (b)(6) 2017 and the index procedure was performed on the same day.The 100% stenosed target lesion was located in the left superficial femoral artery (sfa) with a reference vessel diameter of 5.5 mm and a length of 125 mm.It was classified as a tasc ii b lesion.The target lesion was treated with pre-dilatation using 4 mm x 150 mm balloon.Following this, a grade c dissection was noted, which was treated with balloon dilatation, and the complication was resolved.Then, the target lesion was treated with 6 x 100 mm and 6 x 80 mm ranger study balloons.Following this intervention, grade c dissection was noted again for which balloon dilatation was performed.However, complication was not resolved.Post dilatation with 5 mm x 100 mm was performed, and grade c dissection was still noted, which was also treated with balloon dilatation however, complication was not resolved.On (b)(6) 2017, the subject was discharged on aspirin and clopidogrel.On (b)(6) 2018, 361 days post index procedure, the subject presented to the protocol scheduled 12 months follow up visit with the symptoms of moderate pain or discomfort in the left limb.The subject was diagnosed with stenosis in the left sfa.No action was taken to treat the event.

• 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: 13042383
• MDR Text Key: 282484276
• Report Number: 2134265-2021-16011
• Device Sequence Number: 1
• Product Code: ONU
• Combination Product (y/n): Y
• Reporter Country Code: CA
• PMA/PMN Number: G160172
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Study,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 12/20/2021

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
• Device Operator: Health Professional
• Device Expiration Date: 02/05/2018
• Device Model Number: 1973-01
• Device Catalogue Number: 1973-01
• Device Lot Number: 1071H17
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 12/10/2021
• Initial Date FDA Received: 12/20/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 02/06/2017
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 76 YR
• Patient Sex: Male
• Patient Race: White