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

Model Number	1260
Medical Device Problem Code	Device Contamination with Chemical or Other Material (2944)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	03/19/2020
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that foreign matter was present on the device.A 6f vl3.5 mach1 guide catheter was selected for use.Prior to use, the physician noticed an object that forms like a blood adhered on both the product and the packing list.No patient complications were reported.
Event or Problem Description
It was reported that foreign matter was present on the device.A 6f vl3.5 mach1 guide catheter was selected for use.Prior to use, the physician noticed an object that forms like a blood adhered on both the product and the packing list.No patient complications were reported.
Additional Manufacturer Narrative
Device evaluated by mfr: returned product consisted of a mach 1 guide catheter.The device was inside the box, and inside the sealed pouch.Inspection revealed a small portion of the outside box label with a 'smudge' of foreign material on it.Inspection of the rest of the device found no other damage or defect.The spectra collected from the foreign matter sample showed additional peaks, when compared to the control sample spectra.This shows that there is something present on the foreign matter sample.Library search was performed on the foreign matter sample spectra and the most spectrally similar result was hemoglobin.This result suggests the presence of dried blood on the box label.

• Brand Name: MACH1
• Common Device Name: CATHETER, PERCUTANEOUS
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; two scimed place; maple grove MN 55311
• MDR Report Key: 9953148
• Report Number: 2134265-2020-04912
• Device Sequence Number: 2814639
• Product Code: DQY
• UDI-Device Identifier: 08714729352082
• UDI-Public: 08714729352082
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• 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,Followup
• Report Date (Section B): 05/27/2020

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: 10/18/2022
• Device Model Number: 1260
• Device Catalogue Number: 1260
• Device Lot Number: 0060211783
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/15/2020
• Initial Date Received by Manufacturer: 03/19/2020
• Supplement Date Received by Manufacturer: 05/14/2020
• Initial Report FDA Received Date: 04/13/2020
• Supplement Report FDA Received Date: 05/27/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1