MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION RANGER; CATHETER, PERCUTANEOUS

Model Number 1177-01

Device Problem Device Contaminated During Manufacture or Shipping (2969)

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

Event Date 09/01/2023

Event Type  malfunction  

Event Description

It was reported that contamination occurred.A 4.0 mm x 40 mm, 135 cm ranger balloon catheter was selected for a dilatation procedure.During preparation, however, the nurse opened the product and noticed contamination in the package before removing the ranger balloon catheter.The packaging was not damaged.The contaminated device was not used, and the procedure was completed using another ranger.There were no patient complications reported.

Manufacturer Narrative

Device evaluation by manufacturer: the complaint device was returned to hemoteq.It could be confirmed that the reported fm on the back side of the compliance chart label is tightly embedded into the paper stock.No fm is loosely adhering to the material.

Event Description

It was reported that contamination occurred.A 4.0 mm x 40 mm, 135 cm ranger balloon catheter was selected for a dilatation procedure.During preparation, however, the nurse opened the product and noticed contamination in the package before removing the ranger balloon catheter.The packaging was not damaged.The contaminated device was not used, and the procedure was completed using another ranger.There were no patient complications reported.

• Brand Name: RANGER
• Type of Device: CATHETER, 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: rachel shields ; 4100 hamline ave n; arden hills, MN 55112 ; 6512422111
• MDR Report Key: 17877080
• MDR Text Key: 324994252
• Report Number: 2124215-2023-51761
• Device Sequence Number: 1
• Product Code: ONU
• Combination Product (y/n): Y
• Reporter Country Code: GM
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 01/31/2024

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: 02/23/2024
• Device Model Number: 1177-01
• Device Catalogue Number: 1177-01
• Device Lot Number: 01697H22
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 09/12/2023
• Initial Date FDA Received: 10/05/2023
• Supplement Dates Manufacturer Received: 01/31/2024
• Supplement Dates FDA Received: 01/31/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/23/2022
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1