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

Model Number	7920
Medical Device Problem Code	Device Contaminated During Manufacture or Shipping (2969)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/01/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
B3 date of event estimated based on aware date.
Event or Problem 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.
Additional Manufacturer Narrative
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 or Problem 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 or Problem 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.

• Brand Name: IMPULSE GUIDE CATHETER
• Common Device Name: 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: 17294474
• Report Number: 2124215-2023-36116
• Device Sequence Number: 4195409
• Product Code: DQO
• UDI-Device Identifier: 08714729188810
• UDI-Public: 08714729188810
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K120495
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 09/28/2023

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
• Operator of Device: Health Professional
• Device Expiration Date: 05/24/2025
• Device Model Number: 7920
• Device Catalogue Number: 7920
• Device Lot Number: 0060465327
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 06/29/2023
• Supplement Date Received by Manufacturer: 07/17/2023; 09/25/2023
• Initial Report FDA Received Date: 07/10/2023
• Supplement Report FDA Received Date: 07/24/2023; 09/28/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 05/24/2023
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown