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

Model Number 24628

Device Problem Material Rupture (1546)

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

Event Date 05/06/2022

Event Type  malfunction  

Event Description

It was reported that a balloon rupture occurred.The 95% stenosed target lesion was located in the severely tortuous and moderately calcified brachium.A 6.00mm/2.0cm/50cm peripheral cutting balloon was selected for use.During the procedure, it was noted that the balloon ruptured upon third inflation at 10 atmospheres for about 5 seconds.The device was removed without any issue and the procedure was completed with another of same device.No complications were reported and the patient was in good condition post procedure.

Manufacturer Narrative

Device evaluated by mfr: the device was returned for evaluation.A visual examination identified that the balloon was not folded which indicates that the device was subjected to positive pressure.The returned device was attached to an encore inflation unit.Positive pressure was applied when liquid was observed to be leaking from a balloon pinhole located approximately 10mm proximal of the distal markerband.An examination of the balloon material and markerbands identified no issues which could potentially have contributed to this complaint.The rated burst pressure for this device is 10 atmospheres as per pcb2cm specification.A visual examination observed no damage to the tip or blades.All blades were present and fully bonded to the balloon surface.A visual and tactile examination identified no kinks or damage to the shaft of the device.No other issues were identified during the product analysis.

Event Description

It was reported that a balloon rupture occurred.The 95% stenosed target lesion was located in the severely tortuous and moderately calcified brachium.A 6.00mm/2.0cm/50cm peripheral cutting balloon was selected for use.During the procedure, it was noted that the balloon ruptured upon third inflation at 10 atmospheres for about 5 seconds.The device was removed without any issue and the procedure was completed with another of same device.No complications were reported and the patient was in good condition post procedure.

• 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: 14355073
• MDR Text Key: 291372606
• Report Number: 2134265-2022-05422
• 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: 06/28/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/11/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 10/13/2023
• Device Model Number: 24628
• Device Catalogue Number: 24628
• Device Lot Number: 0028193747
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 06/14/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/13/2021
• 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