MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION NC EMERGE; CATHETERS, TRANSLUMINAL CORONARY ANGIOPLASTY, PERCUTANEOUS

Model Number 7213

Device Problem Packaging Problem (3007)

Patient Problem No Patient Involvement (2645)

Event Date 03/12/2019

Event Type  malfunction  

Manufacturer Narrative

Device evaluated by mfr: the device was returned for analysis.The outer shaft, inner shaft, balloon and tip were visually and microscopically examined.The shelf box and device pouch were visually inspected.Visual examination revealed that the seal on the shelf box is open.The device pouch was taken out and inspected and it was verified that the device pouch has been open.The dfu manual that goes with the device is no longer in the shelf box.On the back of the device pouch there is a vertical cut on the white section 114mm from the left side and approximately 47mm long.There is a tear approximately 19mm long that connects with the cut line.There is a vertical cut on the clear section approximately 112mm from the left side and is approximately 35mm long.When the contents in the pouch was removed a cut can be seen on the front.The front label is blocking the cut, so it can only be seen from the back.The cut is approximately 113mm from the left and is approximately 45mm long.All the cuts appear to line up.Microscopic examination revealed no additional damages.The balloon is still inside the hoop with the product mandrel and balloon protector in the manufactured position.Operations engineering also reviewed the cut in the device pouch.Because the cut does not go thru the front label they decided to peel the label to confirm if the line is an actual cut.After the label was peeled off light pressure was applied, and the cut can be seen separating.Inspection of the remainder of the device presented no other damage or irregularities.Product analysis confirmed there is a cut on the device pouch.

Event Description

It was reported that the product was not sterile.A 3.00mm x 15mm nc emerge balloon catheter was unpacked.However, it was noted that the internal packaging was cut open.The device was not introduced into the patient.No patient serious injury nor complications were reported.

• Brand Name: NC EMERGE
• Type of Device: CATHETERS, TRANSLUMINAL CORONARY ANGIOPLASTY, PERCUTANEOUS
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; two scimed place; maple grove MN 55311
• Manufacturer (Section G): BOSTON SCIENTIFIC SCIMED, INC; two scimed place; maple grove MN 55311
• Manufacturer Contact: sonali arangil ; two scimed place; maple grove, MN 55311 ; 6515827403
• MDR Report Key: 8486492
• MDR Text Key: 141021855
• Report Number: 2134265-2019-03363
• Device Sequence Number: 1
• Product Code: LOX
• UDI-Device Identifier: 08714729846529
• UDI-Public: 08714729846529
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K141236
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 04/05/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/05/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 11/19/2020
• Device Model Number: 7213
• Device Catalogue Number: 7213
• Device Lot Number: 0022967241
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/22/2019
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/13/2019
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/20/2018
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1