MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION MACH1; CATHETER, PERCUTANEOUS

Model Number	24970
Medical Device Problem Code	Unsealed Device Packaging (1444)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/17/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Facility name - (b)(6) hospital.Initial reporter address 1 - (b)(6).
Event or Problem Description
It was reported that device sterility was compromised.The target lesion was located at the renal artery.A mach1 guide catheter was selected for use.During unpacking, it was noted that the inner packaging of the device was damaged, and gas was leaking.The procedure was completed with another of the same device.No patient complications were reported.
Additional Manufacturer Narrative
(b)(6).The device was returned for analysis.No packaging was sent back with the device.The devices shaft and tip were analyzed for any damage.The catheter shaft showed no damage.Inspection of the remainder of the device revealed no damage or irregularities.
Event or Problem Description
It was reported that device sterility was compromised.The target lesion was located at the renal artery.A mach1 guide catheter was selected for use.During unpacking, it was noted that the inner packaging of the device was damaged, and gas was leaking.The procedure was completed with another of the same device.No patient complications were reported.It was further reported that catheter showed no damage.

• Brand Name: MACH1
• Common Device Name: CATHETER, PERCUTANEOUS
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; wo scimed place; maple grove MN 55311
• Manufacturer (Section G): FLEXTRONICS INTERNATIONL EUROPE B V; 6201 america center drive; san jose CA 95002
• Manufacturer Contact: jeff wallner ; 4100 hamline ave n; arden hills, MN 55112 ; 6515811560
• MDR Report Key: 16724186
• Report Number: 2124215-2023-16954
• Device Sequence Number: 18130038
• Product Code: DQY
• UDI-Device Identifier: 08714729403654
• UDI-Public: 08714729403654
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: K020028
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative,Distributor
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 06/01/2023

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: 03/24/2025
• Device Model Number: 24970
• Device Catalogue Number: 24970
• Device Lot Number: 0060357154
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 03/21/2023
• Supplement Date Received by Manufacturer: 05/10/2023
• Initial Report FDA Received Date: 04/12/2023
• Supplement Report FDA Received Date: 06/01/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/24/2022
• 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 Age: 63 YR
• Patient Sex: Male
• Patient Weight: 72 KG