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

Model Number 24630

Device Problem Device Contamination with Chemical or Other Material (2944)

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

Event Date 07/15/2021

Event Type  malfunction  

Event Description

It was reported that a white hair was present on the opened kit.A 5.00mm/2.0cm/90cm peripheral cutting balloon was selected for use.During removal of the cutting balloon, a piece that looks like a white hair was noticed in the opened kit, on the catheter table.The device was discarded at the facility and there was no evidence of damage noticed, after use.There were no patient complications reported.

Manufacturer Narrative

Device evaluated by manufacturer: the device was not returned for analysis.A sample of foreign material (fm) was returned for analysis.A microscopic examination found the sample to have a synthetic appearance and measured approximately 40mm.Ftir analysis was carried out on the fm which confirmed its composition to be an 80% match to polyethylene terephthalate (pet).No other issues were identified during analysis.

Event Description

It was reported that a white hair was present on the opened kit.A 5.00mm/2.0cm/90cm peripheral cutting balloon was selected for use.During removal of the cutting balloon, a piece that looks like a white hair was noticed in the opened kit, on the catheter table.The device was discarded at the facility and there was no evidence of damage noticed, after use.There were no patient complications 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: 12272125
• MDR Text Key: 264938157
• Report Number: 2134265-2021-09887
• 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: 09/07/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/03/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 01/09/2023
• Device Model Number: 24630
• Device Catalogue Number: 24630
• Device Lot Number: 0026606385
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 08/17/2021
• Patient Sequence Number: 1