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

Model Number 24628

Device Problems Device-Device Incompatibility (2919); Material Deformation (2976)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 05/01/2019

Event Type  malfunction  

Manufacturer Narrative

Date of event is an estimated date based off the aware date as the exact event date was not reported.

Event Description

It was reported that the blade was lifted.The 95% stenosed target lesion was located in the brachial artery.A 6.00mm/50cm/2cm peripheral cutting balloon was selected for use.During procedure, it was noted that the tip of the non-bsc sheath got torn due to the blade of the balloon.The working height of the blade of the balloon was higher than usual as it was noted to be lifted.The procedure was completed with this device.No patient complications were noted.

Event Description

It was reported that the blade was lifted.The 95% stenosed target lesion was located in the brachial artery.A 6.00mm/50cm/2cm peripheral cutting balloon was selected for use.During procedure, it was noted that the tip of the non-bsc sheath got torn due to the blade of the balloon.The working height of the blade of the balloon was higher than usual as it was noted to be lifted.The procedure was completed with this device.No patient complications were noted.

Manufacturer Narrative

Date of event is an estimated date based off the aware date as the exact event date was not reported.Device evaluated by manufacturer: the device was returned for analysis.The pcb device was returned alongside a 6fr non boston scientific introducer sheath.A visual examination identified that the balloon was not folded which indicates that the balloon was subjected to positive pressure.The device was attached to encore inflation device and inflated to its rated burst pressure of 10 atmospheres.The inflation device was verified before and after using the druck.No issues were noted with the balloon or blades.The balloon deflated without issue when negative pressure was applied.All blades were fully bonded onto the balloon with no issues identified that may have led to the complaint.No issues were noted with the tip section of the device.A visual and microscopic examination found no issue with the markerbands.A visual and tactile examination found no issues.A 6fr sheath is recommended for pcb 6.00mm balloon diameters.A 39mm cut was identified along the shaft of the non-boston scientific 6fr introducer sheath shaft that was consistent with damage caused by one of the blades.No other issues were identified during the product analysis.

• 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
• MDR Report Key: 8730692
• MDR Text Key: 149073290
• Report Number: 2134265-2019-07356
• Device Sequence Number: 1
• Product Code: LIT
• Combination Product (y/n): N
• PMA/PMN Number: K070951
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,distri
• Type of Report: Initial,Followup
• Report Date: 08/01/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/25/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 01/23/2021
• Device Model Number: 24628
• Device Catalogue Number: 24628
• Device Lot Number: 0023239475
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/11/2019
• Date Manufacturer Received: 07/10/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: INTRODUCER SHEATH- MEDIKIT VAIVT A 6FR; INTRODUCER SHEATH- MEDIKIT VAIVT A 6FR; INTRODUCER SHEATH- MEDIKIT VAIVT A 6FR