MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION AGENT; CATHETERS, TRANSLUMINAL CORONARY ANGIOPLASTY, PERCUTANEOUS

Model Number 3825

Device Problems Device Contamination with Chemical or Other Material (2944); Material Integrity Problem (2978)

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

Event Date 11/30/2022

Event Type  malfunction  

Event Description

It was reported that foreign material was noted on the device.A 2.00 mm x 15.00 mm agent drug coated balloon (dcb) was selected for treatment.Prior to entering the patient, foreign material was noticed on the drug coated part of the device.The drug coating was also reported to be non-uniform.An additional agent dcb was used to complete the procedure with no patient complications.

Event Description

It was reported that foreign material was noted on the device.A 2.00 mm x 15.00 mm agent drug coated balloon (dcb) was selected for treatment.Prior to entering the patient, foreign material was noticed on the drug coated part of the device.The drug coating was also reported to be non-uniform.An additional agent dcb was used to complete the procedure with no patient complications.

Manufacturer Narrative

Device evaluated by manufacturer: returned product consisted of an agent (dcb) balloon catheter.The device was visually and microscopically examined.There was no balloon protector or shipping mandrel returned with the device.There was no sign of fluids within the device.The balloon folds were intact with coating present.There was no damage or irregularities found to the device.Product analysis could not confirm the reported event as the condition of the coating showed no signs of damage or issue.Photo media analysis was provided and revealed that what is visible is part of the drug coating, which most likely is flaking off due to handling of the device.Otherwise, coating is okay.

• Brand Name: AGENT
• Type of Device: CATHETERS, TRANSLUMINAL CORONARY ANGIOPLASTY, PERCUTANEOUS
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 300 boston scientific way; marlborough MA 01752
• Manufacturer (Section G): HEMOTEQ AG; adenauerstrasse 15; wuerselen 52146 ; GM 52146
• Manufacturer Contact: jeff wallner ; 4100 hamline ave n; arden hills, MN 55112 ; 6515811560
• MDR Report Key: 15945978
• MDR Text Key: 305176111
• Report Number: 2124215-2022-51083
• Device Sequence Number: 1
• Product Code: LOX
• Combination Product (y/n): Y
• Reporter Country Code: MY
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 06/21/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/08/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 11/26/2023
• Device Model Number: 3825
• Device Catalogue Number: 3825
• Device Lot Number: 07526H21
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 06/13/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/26/2021
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Age: 48 YR
• Patient Sex: Male
• Patient Weight: 57 KG
• Patient Race: Asian