MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION EXPO GUIDE CATHETER; CATHETER, INTRAVASCULAR, DIAGNOSTIC

Device Problem Device Contaminated During Manufacture or Shipping (2969)

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

Event Date 06/01/2023

Event Type  malfunction  

Manufacturer Narrative

B3 date of event estimated based on aware date.

Event Description

It was reported that device sterility was compromised.Upon arrival, it was noted that an expo catheter had debris stuck on its packaging.Bits of cardboard and other fragments were lodged in the top of the package as well as in the inside of the individual white cardboard packaging.The device could not be placed in a clean room since it was covered with non-sterile debris.

Event Description

It was reported that device sterility was compromised.Upon arrival, it was noted that an expo catheter had debris stuck on its packaging.Bits of cardboard and other fragments were lodged in the top of the package as well as in the inside of the individual white cardboard packaging.The device could not be placed in a clean room since it was covered with non-sterile debris.

Manufacturer Narrative

B3 date of event estimated based on aware date.The device was not returned for analysis; therefore, a technical analysis could not be performed.Media provided by the site depicted foreign material/debris on the inner pouch packaging confirming the reported event.

• Brand Name: EXPO GUIDE CATHETER
• Type of Device: CATHETER, INTRAVASCULAR, DIAGNOSTIC
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 300 boston scientific way; marlborough MA 01752
• Manufacturer (Section G): FLEXTRONICS INTERNATIONL EUROPE B V; 6201 america center drive; san jose CA 95002
• Manufacturer Contact: rachel shields ; 4100 hamline ave n; arden hills, MN 55112 ; 6512422111
• MDR Report Key: 17294914
• MDR Text Key: 319056260
• Report Number: 2124215-2023-36141
• Device Sequence Number: 1
• Product Code: DQO
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date: 09/28/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/10/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 09/25/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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