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

Model Number	24974
Medical Device Problem Codes	Material Integrity Problem (2978); Packaging Problem (3007)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	11/14/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Mfr site address 1: (b)(4).
Event or Problem Description
It was reported that the inner product packaging was compromised.A mach 1 guiding catheter was selected for use.Prior to usage it was noticed that the inner package was compromised.No patient complications were reported.
Additional Manufacturer Narrative
Device evaluated by mfr: analysis of the tip, sheath and hub/strain relief included microscopic and visual inspection.Inspection of the device found no other damage or defect.The reported packaging damage could not be confirmed, as the packaging was not returned for analysis.G1: mfr site address 1 - c.Industrial lt.001 mz.105 no.20905 int.A.
Event or Problem Description
It was reported that the inner product packaging was compromised.A mach 1 guiding catheter was selected for use.Prior to usage it was noticed that the inner package was compromised.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: 9418137
• Report Number: 2134265-2019-15087
• Device Sequence Number: 19455551
• Product Code: DQY
• UDI-Device Identifier: 08714729404118
• UDI-Public: 08714729404118
• 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,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 01/08/2020

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: 10/25/2021
• Device Model Number: 24974
• Device Catalogue Number: 24974
• Device Lot Number: 0060155624
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/09/2019
• Initial Date Received by Manufacturer: 11/20/2019
• Supplement Date Received by Manufacturer: 12/20/2019
• Initial Report FDA Received Date: 12/05/2019
• Supplement Report FDA Received Date: 01/08/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 61 YR
• Patient Weight: 68