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

Model Number 24628

Device Problem Detachment of Device or Device Component (2907)

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

Event Date 12/10/2021

Event Type  malfunction  

Manufacturer Narrative

(b)(6).

Event Description

It was reported that the blade was detached.The 90% stenosed target lesion was located in the shunt vein.A 6.00mm / 2.0cm / 50cm peripheral cutting balloon was selected for use.During the procedure, it was noted that about half of the blade on the hub side was detached.The device was simply removed and the procedure was completed without replacing the device.There were no patient's complications reported.

Event Description

It was reported that the blade was detached.The 90% stenosed target lesion was located in the shunt vein.A 6.00mm / 2.0cm / 50cm peripheral cutting balloon was selected for use.During the procedure, it was noted that about half of the blade on the hub side was detached.The device was simply removed and the procedure was completed without replacing the device.There were no patient's complications reported.

Manufacturer Narrative

E1.Initial reporter address 1: (b)(6).Device evaluated by manufacturer: the device was returned for analysis.A visual examination of the returned device identified that the balloon had been inflated and was not refolded.It is not known when the balloon was subjected to positive pressure.The balloon of the device was visually examined, and no issues were noted that may have potentially contributed to the complaint incident.A visual examination of the returned device identified that 9mm of blade were noted to have lifted on one of the blades.All other blades were present and fully bonded to the balloon surface.No issues were noted with the tip section of the device.A visual examination found no issue with the markerbands.A visual and tactile examination identified no kinks or damage to the shaft of the returned 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 IRELAND LIMITED; ballybrit business park; galway ; EI
• Manufacturer Contact: jay johnson ; two scimed place; maple grove, MN 55311 ; 7634942574
• MDR Report Key: 13212426
• MDR Text Key: 283600317
• Report Number: 2134265-2021-16405
• Device Sequence Number: 1
• Product Code: LIT
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K070951
• 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
• Report Date: 02/25/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/10/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 07/13/2023
• Device Model Number: 24628
• Device Catalogue Number: 24628
• Device Lot Number: 0027654693
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/20/2022
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/04/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/13/2021
• 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
• Treatment: GUIDEWIRE-FUGA; GUIDEWIRE-FUGA; VAIVT A 6FR; VAIVT A 6FR