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

Model Number 7920

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 impulse guide 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 sterility of the device was compromised.An impulse and expo guide catheter did arrive with a debris stuck on its packaging.Bits of cardboard and other fragments are lodged in the top of the package as well as in the inside of the individual white cardboard packaging.The sterility can be compromised upon opening of the devices since the fragments can fall in.No patient involvement was reported.

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.The photos provided by the site depict foreign material/debris on the inner pouch packaging confirming the reported event.

Event Description

It was reported that sterility of the device was compromised.An impulse and expo guide catheter did arrive with a debris stuck on its packaging.Bits of cardboard and other fragments are lodged in the top of the package as well as in the inside of the individual white cardboard packaging.The sterility can be compromised upon opening of the devices since the fragments can fall in.No patient involvement was reported.

• Brand Name: IMPULSE 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: 17294968
• MDR Text Key: 318927288
• Report Number: 2124215-2023-36113
• Device Sequence Number: 1
• Product Code: DQO
• UDI-Device Identifier: 08714729188810
• UDI-Public: 08714729188810
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K120495
• 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,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
• Device Model Number: 7920
• Device Catalogue Number: 7920
• Device Lot Number: 0060465327
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 09/26/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/24/2023
• 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