MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION 2CM PERIPHERAL CUTTING BALLOON; CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINA

Model Number 24634

Device Problems Break (1069); Inflation Problem (1310); Difficult to Remove (1528)

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

Event Date 01/13/2022

Event Type  malfunction  

Event Description

It was reported that the balloon was difficult to remove, and the blades broke.A 2cm peripheral cutting balloon (pcb) was selected for use in a biliary percutaneous cutting balloon procedure.During the procedure while inflating the balloon, it was observed that it did not open completely.The balloon was deflated and withdrawn.While withdrawing, the balloon became stuck in the introducer sheath, and the blades broke.The procedure was not completed since another pcb was unavailable.No patient complications were reported, and the patient was stable following the procedure.

Event Description

It was reported that the balloon was difficult to remove, and the blades broke.A 2cm peripheral cutting balloon (pcb) was selected for use in a biliary percutaneous cutting balloon procedure.During the procedure while inflating the balloon, it was observed that it did not open completely.The balloon was deflated and withdrawn.While withdrawing, the balloon became stuck in the introducer sheath, and the blades broke.The procedure was not completed since another pcb was unavailable.No patient complications were reported, and the patient was stable following the procedure.It was further reported that this was a balloon cholangioplasty procedure, and the anatomy was a bit tortuous.The balloon was fully deflated when it was withdrawn and became stuck in a 7f introducer sheath.The blades were partially detached.

Event Description

It was reported that the balloon was difficult to remove, and the blades broke.A 2cm peripheral cutting balloon (pcb) was selected for use in a biliary percutaneous cutting balloon procedure.During the procedure while inflating the balloon, it was observed that it did not open completely.The balloon was deflated and withdrawn.While withdrawing, the balloon became stuck in the introducer sheath, and the blades broke.The procedure was not completed since another pcb was unavailable.No patient complications were reported, and the patient was stable following the procedure.It was further reported that this was a balloon cholangioplasty procedure, and the anatomy was a bit tortuous.The balloon was fully deflated when it was withdrawn and became stuck in a 7f introducer sheath.The blades were partially detached.

Manufacturer Narrative

Device eval by manufacturer: the peripheral cutting balloon was returned for analysis.A visual examination was performed on the returned device.It was noted that approximately 15mm proximal section of one blade was completely detached from its blade pad.The remaining 5mm distal section of blade and the entire blade pad remained bonded to the balloon material.The damage identified is consistent with excessive force being applied when resistance is encountered during the withdrawal of the device through the sheath.All other blades were intact and fully bonded to the balloon material.A visual examination identified that the balloon was not folded, which indicates that the balloon was subjected to positive pressure.A balloon longitudinal tear was identified beginning approximately 3mm proximal of the distal markerband and extending approximately 3mm proximally.An examination of the balloon material and distal markerband identified no issues that could potentially have contributed to this complaint.No issue was observed with the tip or markerbands of the device which could have contributed to the complaint incident.A visual and tactile examination found no kinks or damage to the shaft of the device.

• Brand Name: 2CM PERIPHERAL CUTTING BALLOON
• Type of Device: CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINA
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; two scimed place; maple grove MN 55311
• Manufacturer (Section G): BOSTON SCIENTIFIC CORPORATION; ballybrit business park; galway ; EI
• Manufacturer Contact: jay johnson ; two scimed place; maple grove, MN 55311 ; 7634942574
• MDR Report Key: 13476756
• MDR Text Key: 285340871
• Report Number: 2134265-2022-01133
• Device Sequence Number: 1
• Product Code: LIT
• Combination Product (y/n): N
• Reporter Country Code: IN
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative,Distributor
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date: 04/26/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/07/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 08/04/2023
• Device Model Number: 24634
• Device Catalogue Number: 24634
• Device Lot Number: 0027775588
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/04/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/04/2021
• 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 Age: 73 YR
• Patient Weight: 70 KG