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 06/02/2022

Event Type  malfunction  

Manufacturer Narrative

(b)(6).

Event Description

It was reported that the blade became lifted.The 99% stenosed target lesion was located in the moderately tortuous and moderately calcified right iliac artery.A 6.00mm/2.0cm/90cm peripheral cutting balloon was selected for use.During the procedure, it was noted that the blade became lifted.The device was removed from the patient's body without any problems and the procedure was completed with a different device.No patient complications were reported.

Manufacturer Narrative

E1 - initial reporter address 1: (b)(6).Device evaluated by mfr: the device was returned for evaluation.A visual and microscopic 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 examined and no issues were noted that may have potentially contributed to the complaint incident.Using an encore inflation units the balloon was inflated to its rated burt pressure (rbp) of 10 atmospheres with no leaks present.The encore was tested using a druck pressure gauge.Using the same encore, a vacuum was pulled and the balloon deflated fully.A visual examination of the returned device identified that 0.6cm of a blade were noted to have lifted on one of the blades.All other blades were present and fully bonded to the balloon surface.All blade pads were fully intact.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 a kink at 59.7cm distal from the strain relief.No other issues were identified during the product analysis.

Event Description

It was reported that the blade became lifted.The 99% stenosed target lesion was located in the moderately tortuous and moderately calcified right iliac artery.A 6.00mm/2.0cm/90cm peripheral cutting balloon was selected for use.During the procedure, it was noted that the blade became lifted.The device was removed from the patient's body without any problems and the procedure was completed with a different device.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
• Manufacturer (Section G): BOSTON SCIENTIFIC IRELAND LIMITED; ballybrit business park; galway ; EI
• Manufacturer Contact: jay johnson ; 4100 hamline ave n; arden hills, MN 55112 ; 6515810888
• MDR Report Key: 14802878
• MDR Text Key: 301362571
• Report Number: 2134265-2022-06929
• 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: 07/27/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/24/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 11/29/2023
• Device Model Number: 24630
• Device Catalogue Number: 24630
• Device Lot Number: 0028461836
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 07/01/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/29/2021
• 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