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

Model Number 24634

Device Problems Contamination (1120); Incomplete or Missing Packaging (2312); Packaging Problem (3007)

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

Event Date 08/20/2021

Event Type  malfunction  

Event Description

It was reported that the device sterility was compromised.A 6.00mm/2.0cm/135cm peripheral cutting balloon was selected for use.During preparation, it was noted that the package had already been opened.Furthermore, the inner package was damage, not intact and not sterile.The procedure was completed with a different device.No patient complications were reported.

Manufacturer Narrative

F10: device code - packaging problem.H6: device code - packaging problem.Device evaluated by manufacturer: the device was returned for analysis.No packaging or box packaging was returned with this device.A visual examination of the device appeared that it was unused.A visual examination of the returned device confirmed that the balloon had not been inflated.No issues or damage was noted with the balloon material, balloon profile or blades.All blades were present and fully bonded to the balloon material.No issues were noted with the tip of the device.A visual and tactile examination identified no issues along the length of the device.No issues were noted with the returned device that could potentially have contributed to the complaint incident.

Event Description

It was reported that the device sterility was compromised.A 6.00mm/2.0cm/135cm peripheral cutting balloon was selected for use.During preparation, it was noted that the package has already been opened.Furthermore, the inner package was damage, not intact and not sterile.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
• MDR Report Key: 12503031
• MDR Text Key: 272456712
• Report Number: 2134265-2021-11458
• Device Sequence Number: 1
• Product Code: LIT
• Combination Product (y/n): N
• 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: 10/12/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 09/12/2021
• Device Model Number: 24634
• Device Catalogue Number: 24634
• Device Lot Number: 0024425612
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/07/2021
• Initial Date Manufacturer Received: 08/30/2021
• Initial Date FDA Received: 09/20/2021
• Supplement Dates Manufacturer Received: 10/01/2021
• Supplement Dates FDA Received: 10/12/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 57 YR
• Patient Weight: 63