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

Model Number	24970
Medical Device Problem Codes	Contamination (1120); Unsealed Device Packaging (1444)
Health Effect - Clinical Code	No Patient Involvement (2645)
Date of Event	07/08/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).
Event or Problem Description
It was reported that the device sterility was compromised.The target lesion was located in the renal artery.A model 6f pv mach 1 was selected for use to view the target lesion.During unpacking, it was noted that there was air leakage and the device was not sterile.The procedure was completed with another with the same device.No patient complications were reported.

• Brand Name: MACH1
• Common Device Name: CATHETER, PERCUTANEOUS
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; two scimed place; maple grove MN 55311
• MDR Report Key: 8851249
• Report Number: 2134265-2019-09017
• Device Sequence Number: 329121
• 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
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 08/01/2019

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: 06/30/2020
• Device Model Number: 24970
• Device Catalogue Number: 24970
• Device Lot Number: 0060070698
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/16/2019
• Initial Report FDA Received Date: 08/01/2019
• Patient Sequence Number: 1
• Patient Age: 59 YR
• Patient Weight: 63