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

Model Number 1973-03

Device Problem Failure to Deflate (4060)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 09/01/2023

Event Type  Injury  

Event Description

It was reported that the balloon failed to deflate.A 5.0 x 100mm, 135cm ranger paclitaxel-coated pta balloon catheter was selected for use in a leg angiogram to treat peripheral arterial disease.The ranger was successfully inflated to nominal pressure for three minutes in the popliteal artery and removed.Then a non-boston scientific stent was deployed.The ranger was again used to post-dilate; however, it would not deflate.The balloon was walked out to proximal to the stent, but it would still not completely deflate.The physician then attempted to pop the balloon with access microneedle and apply negative pressure.After approximately 15 minutes of trying to deflate, the balloon was replaced with a different device to complete the procedure.No patient complications were reported.

Manufacturer Narrative

Device evaluation by manufacturer: 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 multiple stretched sections along the inflation lumen.The guidewire lumen is separated from the hub.Microscopic examination revealed no additional damages.Inspection of the remainder of the device presented no other damage or irregularities.Product analysis found damage that would have contributed to the failure to deflate.

Event Description

It was reported that the balloon failed to deflate.A 5.0 x 100mm, 135cm ranger paclitaxel-coated pta balloon catheter was selected for use in a leg angiogram to treat peripheral arterial disease.The ranger was successfully inflated to nominal pressure for three minutes in the popliteal artery and removed.Then a non-boston scientific stent was deployed.The ranger was again used to post-dilate; however, it would not deflate.The balloon was walked out to proximal to the stent, but it would still not completely deflate.The physician then attempted to pop the balloon with a microneedle and apply negative pressure.After approximately 15 minutes of trying to deflate, the balloon was replaced with a different device to complete the procedure.No patient complications were reported.

• Brand Name: RANGER PACLITAXEL-COATED PTA BALLOON CATHETER
• Type of Device: DRUG-ELUTING PERIPHERAL TRANSLUMINAL ANGIOPLASTY CATHETER
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 300 boston scientific way; marlborough MA 01752
• Manufacturer (Section G): HEMOTEQ AG; adenauerstrasse 15; wuerselen 52146 ; GM 52146
• Manufacturer Contact: rachel shields ; 4100 hamline ave n; arden hills, MN 55112 ; 6512422111
• MDR Report Key: 17821586
• MDR Text Key: 324305185
• Report Number: 2124215-2023-52334
• Device Sequence Number: 1
• Product Code: ONU
• UDI-Device Identifier: 08714729975984
• UDI-Public: 08714729975984
• Combination Product (y/n): Y
• Reporter Country Code: US
• PMA/PMN Number: P190019
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 10/17/2023

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
• Device Operator: Health Professional
• Device Model Number: 1973-03
• Device Catalogue Number: 1973-03
• Device Lot Number: 07354H22
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 09/01/2023
• Initial Date FDA Received: 09/26/2023
• Supplement Dates Manufacturer Received: 10/04/2023
• Supplement Dates FDA Received: 10/17/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/09/2022
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention