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

Model Number 24628

Device Problems Difficult to Remove (1528); Detachment of Device or Device Component (2907); Material Twisted/Bent (2981)

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

Event Date 03/06/2021

Event Type  Injury  

Event Description

It was reported that blade detachment occurred.The 75% stenosed target lesion was located in the moderately tortuous basilic vein upperarm-underarm.A 5.00mmx2.0cmx50cm peripheral cutting balloon was selected for use.During the procedure, the lesion was dilated twice at 8 atmospheres with this device, and the loop graph and anastomosis were dilated once with 8 atmospheres.After dilation, resistance was felt during removal.So the physician went a little further and this device was dilated to 6 atmospheres once.Then, removal was tried again and it was able to be removed smoothly.When removed, it was found that one blade was missing.The blade was checked on the fluoroscopy and it was found stuck in the upper arm - armpit area.An incision was made in the brachial vein and forceps were used to try to grab it, but it was unable to be retrieved.Then, a 12mm mustang balloon catheter was used and dilated next to the blade and a gooseneck snare was used to grab the mustang together with the blade and the whole thing was pulled out.When the recovered blade was closely inspected, it seems to be bent in one direction or another.The procedure was completed without any device replacement.No patient complications were reported.

Manufacturer Narrative

Device evaluated by mfr: the device was returned for analysis.The recommended sheath size for this device as per pcb2cm specification is a minimum 6fr.The sheath used by the customer was not returned for analysis.A visual examination identified that the balloon was not folded which indicates that the balloon was subjected to positive pressure.To carry out a leak test the returned device was attached to an encore inflation unit and positive pressure was applied.The balloon was inflated to its rate of burst pressure for 30 seconds using digital timer without issue.The inflation device was verified at 10 atmospheres, before and after use with a calibrated pressure gauge.No issues were identified with balloon the balloon material.A microscopic examination identified that one of the blades had completely detached from the balloon material.The detached blade was not returned for analysis.A section measuring approximately 16mm of the distal end of the blade pad was also detached from the balloon material.The proximal section measuring approximately 4mm remained bonded to the balloon material.This type of damage is consistent with excessive force being applied to the device when encountering resistance.No issues or damage was noted to any of the other blades of the device.All other blades and blade pads remained fully bonded to the balloon material.A microscopic examination identified found no damage or issues with the tip of the device.A visual and microscopic examination found no issue with the markerbands.A visual and tactile examination found no damage or kinks to the shaft of the device.No other issues were identified during the product analysis.

Event Description

It was reported that blade detachment occurred.The 75% stenosed target lesion was located in the moderately tortuous basilic vein upperarm-underarm.A 5.00mmx2.0cmx50cm peripheral cutting balloon was selected for use.During the procedure, the lesion was dilated twice at 8 atmospheres with this device, and the loop graph and anastomosis were dilated once with 8 atmospheres.After dilation, resistance was felt during removal.So the physician went a little further and this device was dilated to 6 atmospheres once.Then, removal was tried again and it was able to be removed smoothly.When removed, it was found that one blade was missing.The blade was checked on the fluoroscopy and it was found stuck in the upper arm - armpit area.An incision was made in the brachial vein and forceps were used to try to grab it, but it was unable to be retrieved.Then, a 12mm mustang balloon catheter was used and dilated next to the blade and a gooseneck snare was used to grab the mustang together with the blade and the whole thing was pulled out.When the recovered blade was closely inspected, it seems to be bent in one direction or another.The procedure was completed without any device replacement.No patient complications were reported.

• 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: 11568923
• MDR Text Key: 242257314
• Report Number: 2134265-2021-03749
• 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: 05/11/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/25/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 12/04/2022
• Device Model Number: 24628
• Device Catalogue Number: 24628
• Device Lot Number: 0026464286
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/01/2021
• Date Manufacturer Received: 04/22/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: GUIDEWIRE - 018GW; GUIDEWIRE - 018GW; INTRODUCER SHEATH - VAIVT ACE 6F3CM; INTRODUCER SHEATH - VAIVT ACE 6F3CM; GUIDEWIRE - 018GW; INTRODUCER SHEATH - VAIVT ACE 6F3CM
• Patient Outcome(s): Required Intervention