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

Model Number	1973-03
Medical Device Problem Codes	Deflation Problem (1149); Inflation Problem (1310)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/31/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(6).
Event or Problem Description
It was reported that a slow balloon deflation occurred.A ranger 4.0mm x 200mm was selected for use during an endovascular treatment for peripheral artery disease.The lesion was 90% stenosed, mildly calcified and moderately tortuous in the superficial femoral artery.The balloon was inflated one time for 180 seconds at 6 atmospheres of pressure.The balloon was noted to be slow to deflate, which was approximately 60-90 seconds in duration.Low pressure was maintained.The procedure was still able to be completed with this device.No patient complications were reported.
Additional Manufacturer Narrative
E1 - initial reporter facility name: (b)(6).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.Visual examination revealed that the inflation lumen is stretched 114.5cm to 116.5cm from the hub.Microscopic examination revealed no additional damages.Inspection of the remainder of the device presented no other damage or irregularities.
Event or Problem Description
It was reported that a slow balloon deflation occurred.A ranger 4.0mm x 200mm was selected for use during an endovascular treatment for peripheral artery disease.The lesion was 90% stenosed, mildly calcified and moderately tortuous in the superficial femoral artery.The balloon was inflated one time for 180 seconds at 6 atmospheres of pressure.The balloon was noted to be slow to deflate, which was approximately 60-90 seconds in duration.Low pressure was maintained.The procedure was still able to be completed with this device.No patient complications were reported.

• Brand Name: RANGER PACLITAXEL-COATED PTA BALLOON CATHETER
• Common Device Name: DRUG-ELUTING PERIPHERAL TRANSLUMINAL ANGIOPLASTY CATHETER
• MDR Report Key: 12516570
• Report Number: 2134265-2021-11888
• Device Sequence Number: 13671133
• Product Code: ONU
• UDI-Device Identifier: 08714729975885
• UDI-Public: 08714729975885
• 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: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 10/21/2021

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: 06/05/2022
• Device Model Number: 1973-03
• Device Catalogue Number: 1973-03
• Device Lot Number: 08344H20
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/21/2021
• Initial Date Received by Manufacturer: 09/01/2021
• Supplement Date Received by Manufacturer: 09/30/2021
• Initial Report FDA Received Date: 09/22/2021
• Supplement Report FDA Received Date: 10/21/2021
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/07/2020
• 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