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	Difficult to Remove (1528); Detachment of Device or Device Component (2907); Failure to Deflate (4060)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/13/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the balloon catheter was not fully deflating and became sheared, resulting in an additional intervention.This ranger global dcb otw 7.0 x 40mm, 135cm was selected for use in a right common iliac angioplasty procedure for in stent restenosis.The lesion was initially dilated with a non boston scientific balloon, then this ranger balloon was used for three minutes, reaching a burst pressure of 14 atm.The distal 10mm of balloon was not deflating completely.Several attempts were made to slightly reinflate then deflate the balloon without success.The sheath, wire, and balloon were removed together, leaving a buddy wire in place to retain access.Upon inspection, the balloon had sheared and the 5mm distal tip was partially caught in the femoral arteriotomy.The balloon procedure was completed, and the patient was transferred to the operating room to remove the portion of balloon material.They were admitted to the hospital following the procedure and were expected to fully recover.The product is expected to be returned.
Additional Manufacturer Narrative
Correction to b5: describe event or problem: added- it was noted that the device was difficult to remove from the sheath.
Event or Problem Description
It was reported that the balloon catheter was not fully deflating and became sheared, resulting in an additional intervention.This ranger global dcb otw 7.0 x 40mm, 135cm was selected for use in a right common iliac angioplasty procedure for in stent restenosis.The lesion was initially dilated with a non boston scientific balloon, then this ranger balloon was used for three minutes, reaching a burst pressure of 14 atm.The distal 10mm of balloon was not deflating completely.Several attempts were made to slightly reinflate then deflate the balloon without success.It was noted that the device was difficult to remove from the sheath.The sheath, wire, and balloon were removed together, leaving a buddy wire in place to retain access.Upon inspection, the balloon had sheared and the 5mm distal tip was partially caught in the femoral arteriotomy.The balloon procedure was completed, and the patient was transferred to the operating room to remove the portion of balloon material.They were admitted to the hospital following the procedure and were expected to fully recover.The product is expected to be returned.

• 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): HEMOTEQ AG; adenauerstrasse 15; wuerselen 52146 ; GM 52146
• Manufacturer Contact: jay johnson ; 4100 hamline ave n; arden hills, MN 55112 ; 6515810888
• MDR Report Key: 16224264
• Report Number: 2124215-2023-01876
• Device Sequence Number: 20183540
• Product Code: ONU
• UDI-Device Identifier: 08714729976240
• UDI-Public: 08714729976240
• Combination Product (Y/N): Y
• Initial Reporter State: FL
• 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): 03/29/2023

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?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 06/02/2024
• Device Model Number: 1973-03
• Device Catalogue Number: 1973-03
• Device Lot Number: 04436H22
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 01/13/2023
• Supplement Date Received by Manufacturer: 03/19/2023
• Initial Report FDA Received Date: 01/23/2023
• Supplement Report FDA Received Date: 03/29/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 06/03/2022
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Age: 70 YR
• Patient Sex: Male
• Patient Ethnicity: Non Hispanic
• Patient Race: White