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

Model Number	1260
Medical Device Problem Codes	Unsealed Device Packaging (1444); Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	No Patient Involvement (2645)
Date of Event	11/06/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Age at time of event: 18 years or older.
Event or Problem Description
It was reported that the packaging seal was compromised.A mach1 guide catheter was selected during a patient procedure.The physician finished using an unspecified device and planned to replace it with the 6f mach1 device.However, upon visual inspection of the packaging of the device, it was noted that the tape/seal was found to be open.No patient complications were reported.
Additional Manufacturer Narrative
Age at time of event: 18 years or older.
Event or Problem Description
It was reported that the packaging seal was compromised.A mach1 guide catheter was selected during a patient procedure.The physician finished using an unspecified device and planned to replace it with the 6f mach1 device.However, upon visual inspection of the packaging of the device, it was noted that the tape/seal was found to be open.No patient complications were reported.It was further reported that the tape of outer pouch(box) was torn and lid of outer pouch(box) was opened.However, the inner pouch was neither compromised nor damaged.
Additional Manufacturer Narrative
Age at time of event: 18 years or older.Mfr site address 2: 20905 int.A.Col.,cd.Industrial.Device evaluated by mfr: investigation was completed.Returned product consisted of a 6f mach 1 guide catheter, folded multiple times inside the pouch.Inspection revealed numerous kinks in the shaft, and damage to the cardboard backing (relative to the shaft kinks).The reported damage (tape open) to the box could not be confirmed as the box was not sent back for analysis and there was no photos of the open tape, but can likely be attributed to handling of the box.The shaft damage (kinks) and tyvek/cardboard packaging damage is likely attributed to shipping the device back for analysis.
Event or Problem Description
It was reported that the packaging seal was compromised.A mach1 guide catheter was selected during a patient procedure.The physician finished using an unspecified device and planned to replace it with the 6f mach1 device.However, upon visual inspection of the packaging of the device, it was noted that the tape/seal was found to be open.No patient complications were reported.It was further reported that the tape of outer pouch(box) was torn and lid of outer pouch(box) was opened.However, the inner pouch was neither compromised nor damaged.

• Brand Name: MACH1
• Common Device Name: CATHETER, PERCUTANEOUS
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; two scimed place; maple grove MN 55311
• MDR Report Key: 8075430
• Report Number: 2134265-2018-62946
• Device Sequence Number: 19374535
• Product Code: DQY
• UDI-Device Identifier: 08714729351221
• UDI-Public: 08714729351221
• 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,distri
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 01/07/2019

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: 08/06/2021
• Device Model Number: 1260
• Device Catalogue Number: 1260
• Device Lot Number: 0060142334
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/28/2018
• Initial Date Received by Manufacturer: 11/06/2018
• Supplement Date Received by Manufacturer: 11/19/2018; 12/19/2018
• Initial Report FDA Received Date: 11/15/2018
• Supplement Report FDA Received Date: 12/05/2018; 01/07/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1