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

Model Number 24630

Device Problem Device Dislodged or Dislocated (2923)

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

Event Date 09/21/2021

Event Type  malfunction  

Event Description

It was reported that the blade was lifted.The 99% stenosed target lesion was located in the moderately tortuous and moderately calcified brachial vein.A 6.00mmx2.0cmx90cm peripheral cutting balloon was selected for use.During the procedure, when this device was removed from the sheath, one of the blades was partially lifted.The procedure has been completed without any problems.There was no patient injury.

Event Description

It was reported that the blade was lifted.The 99% stenosed target lesion was located in the moderately tortuous and moderately calcified brachial vein.A 6.00mmx2.0cmx90cm peripheral cutting balloon was selected for use.During the procedure, when this device was removed from the sheath, one of the blades was partially lifted.The procedure has been completed without any problems.There was no patient injury.

Manufacturer Narrative

Device evaluated by mfr: a pcb 6.00mm / 2.0cm / 90cm otw - ous 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 and microscopically examined, and no issues were noted that may have potentially contributed to the complaint incident.A visual examination of the returned device identified that 5mm 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 and microscopic examination found no issue with the markerbands.A visual and tactile examination identified no kinks or damage to the shaft of the returned device.This concludes 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
• 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: 12573442
• MDR Text Key: 274715943
• Report Number: 2134265-2021-12296
• 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: 11/08/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/04/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 04/26/2023
• Device Model Number: 24630
• Device Catalogue Number: 24630
• Device Lot Number: 0027206069
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/11/2021
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/20/2021
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/26/2021
• 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