MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION RANGER SL; CATHETER, PERCUTANEOUS

Model Number 1584-01

Device Problems Break (1069); Material Rupture (1546); Adverse Event Without Identified Device or Use Problem (2993)

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

Event Date 12/18/2023

Event Type  Injury  

Manufacturer Narrative

A3 - weight: 67.5 kg.

Event Description

It was reported that balloon rupture occurred.The 75% stenosed target lesion was located in the mildly tortuous and mildly calcified straight geometry vessel in the lower limb.A 2.5 standard balloon was advanced for pre-dilation and a 2.50mm x 150mm, 150cm ranger sl drug-coated balloon catheter was selected lower extremity arteriography and balloon dilation.During the procedure, the loading tool was used in advancing the sheath into the y-valve.The nominal pressure was first increased to 10 atmospheres to the standard operation, but the balloon was not fully inflated.After the pressure reached 20 atmospheres, the balloon was fully inflated.Upon third inflation, the pressure was increased to nearly 30 atmospheres, but the balloon burst.The device was withdrawn, however, when the balloon body entered the long sheath for about 10cm, it was difficult to pull back.The entire balloon body and the shaft got broke 130cm from the hub.A v-18 guidewire was inserted into the long sheath and a balloon with 2-diameter was advanced into the fractured balloon body.The 2-diameter balloon was dilated under pressure to squeezed it against the inner wall of the long sheath.The fractured balloon together with the long sheath were removed as a whole.The procedure was completed.No complications were reported, and the patient's status was stable.

Event Description

It was reported that balloon rupture occurred.The 75% stenosed target lesion was located in the mildly tortuous and mildly calcified straight geometry vessel in the lower limb.A 2.5 standard balloon was advanced for pre-dilation and a 2.50mm x 150mm, 150cm ranger sl drug-coated balloon catheter was selected lower extremity arteriography and balloon dilation.During the procedure, the loading tool was used in advancing the sheath into the y-valve.The nominal pressure was first increased to 10 atmospheres to the standard operation, but the balloon was not fully inflated.After the pressure reached 20 atmospheres, the balloon was fully inflated.Upon third inflation, the pressure was increased to nearly 30 atmospheres, but the balloon burst.The device was withdrawn, however, when the balloon body entered the long sheath for about 10cm, it was difficult to pull back.The entire balloon body and the shaft got broke 130cm from the hub.A v-18 guidewire was inserted into the long sheath and a balloon with 2-diameter was advanced into the fractured balloon body.The 2-diameter balloon was dilated under pressure to squeezed it against the inner wall of the long sheath.The fractured balloon together with the long sheath were removed as a whole.The procedure was completed.No complications were reported, and the patient's status was stable.

Manufacturer Narrative

Updated d4 lot number from 10551h22 to 02124h23.A3 - weight: 67.5 kg.Device evaluated by mfr: the device was received for analysis.Visual examination revealed that the balloon protector is on the shaft of the device.There are multiple kinks along the shaft of the device.The guidewire lumen is separated 142.9cm from the hub and appears to have been stretched prior to separating.The inflation lumen is separated 145.6cm from the hub and appears to have burst.Microscopic examination revealed no additional damages.Product analysis found that the shaft burst, and the guidewire lumen is separated.

• Brand Name: RANGER SL
• Type of Device: CATHETER, PERCUTANEOUS
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 300 boston scientific way; marlborough MA 01752
• Manufacturer (Section G): BOSTON SCIENTIFIC CORPORATION; adenauerstrasse 15; wuerselen 52146 ; GM 52146
• Manufacturer Contact: rachel shields ; 4100 hamline ave n; arden hills, MN 55112 ; 6512422111
• MDR Report Key: 18476308
• MDR Text Key: 332448642
• Report Number: 2124215-2023-74569
• Device Sequence Number: 1
• Product Code: ONU
• Combination Product (y/n): Y
• Reporter Country Code: CH
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Health Professional,Company Representative,Distributor
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 02/15/2024

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: 1584-01
• Device Catalogue Number: 1584-01
• Device Lot Number: 02124H23
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 12/19/2023
• Initial Date FDA Received: 01/09/2024
• Supplement Dates Manufacturer Received: 02/01/2024
• Supplement Dates FDA Received: 02/15/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/06/2023
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 63 YR
• Patient Sex: Female