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	Failure to Advance (2524); Material Integrity Problem (2978)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/19/2022
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported coating peeled off.During a superficial femoral artery (sfa) occlusion case, a 5.0 x 100mm, 135cm ranger drug-coated balloon (dcb) was selected for use.Multiple attempts were made to cross the lesion with the ranger, but it was unsuccessful even after the lesion was dilated.The device was inserted inside the patient twice, and there was a concern that the drug coating might have peeled off.Another 5mm x 150mm ranger dcb was opened, and the procedure was completed after crossing the lesion.There were no patient complications.
Additional Manufacturer Narrative
Device evaluated by mfr: returned product consisted of a ranger drug coated balloon catheter.The outer shaft, inner shaft, balloon and tip were visually and microscopically examined and revealed no damage.The loading tool is still coving the balloon and the drug coating is still visible.There was no evidence of any damage or irregularities contributing to the reported crossing difficulty, which could not be confirmed because the clinical circumstances could not be replicated.Product analysis confirmed the drug coating is still visible.
Event or Problem Description
It was reported coating peeled off.During a superficial femoral artery (sfa) occlusion case, a 5.0 x 100mm, 135cm ranger drug-coated balloon (dcb) was selected for use.Multiple attempts were made to cross the lesion with the ranger, but it was unsuccessful even after the lesion was dilated.The device was inserted inside the patient twice, and there was a concern that the drug coating might have peeled off.Another 5mm x 150mm ranger dcb was opened, and the procedure was completed after crossing the lesion.There were no patient complications.

• 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
• Manufacturer (Section G): BOSTON SCIENTIFIC CORPORATION; 500 commander shea boulevard; quincy MA 02171
• Manufacturer Contact: jay johnson ; two scimed place; maple grove, MN 55311 ; 7634942574
• MDR Report Key: 13522296
• Report Number: 2134265-2022-01498
• Device Sequence Number: 4385419
• Product Code: ONU
• UDI-Device Identifier: 08714729975984
• UDI-Public: 08714729975984
• Combination Product (Y/N): Y
• Initial Reporter Country: JA
• 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: Foreign,Health Professional,Company Representative,Distributor
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 03/22/2022

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: 04/29/2022
• Device Model Number: 1973-03
• Device Catalogue Number: 1973-03
• Device Lot Number: 0027455807
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 01/20/2022
• Supplement Date Received by Manufacturer: 03/04/2022
• Initial Report FDA Received Date: 02/14/2022
• Supplement Report FDA Received Date: 03/23/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/29/2020
• 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
• Concomitant Medical Products and Therapy/Usage Dates: GUIDEWIRE: JUPITER; GUIDEWIRE: JUPITER; INTRODUCER SHEATH: PARENT; INTRODUCER SHEATH: PARENT
• Patient Sex: Unknown