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

Model Number 1260

Device Problems Unsealed Device Packaging (1444); Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem No Patient Involvement (2645)

Event Date 11/06/2018

Event Type  malfunction  

Manufacturer Narrative

Age at time of event: 18 years or older.

Event 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.

Manufacturer Narrative

Age at time of event: 18 years or older.

Event 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.

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 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
• Type of Device: CATHETER, PERCUTANEOUS
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; two scimed place; maple grove MN 55311
• MDR Report Key: 8075430
• MDR Text Key: 127349888
• Report Number: 2134265-2018-62946
• Device Sequence Number: 1
• Product Code: DQY
• UDI-Device Identifier: 08714729351221
• UDI-Public: 08714729351221
• Combination Product (y/n): N
• PMA/PMN Number: K020028
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,distri
• Type of Report: Initial,Followup,Followup
• Report Date: 01/07/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/15/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: 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
• Date Manufacturer Received: 12/19/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1