MAUDE Adverse Event Report: BOSTON SCIENTIFIC - MAPLE GROVE NC EMERGE®; CATHETERS, TRANSLUMINAL CORONARY ANGIOPLASTY, PERCUTANEOUS

Model Number H7493927612270

Device Problem Contamination /Decontamination Problem (2895)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Type  malfunction  

Manufacturer Narrative

Age at time of event: 18 years or older.(b)(4).

Event Description

It was reported that sterility was compromised.During unpacking of a 2.75 mm x 12 mm nc emerge® balloon catheter, it was noted that there was a dirt on the back of compliance chart in the sterile pouch.The device was used without issue and the procedure was completed.No patient complications were reported.

Manufacturer Narrative

Device evaluated by mfr: returned product consisted of a nc emerge compliance chart.The device and packaging was not returned for analysis.The packaging was examined.The compliance chart has a piece of foreign matter on the back side.The reported foreign matter was confirmed via product analysis; however it is inconclusive of when the fm appeared on the compliance chart as the package was returned opened.The investigation conclusion is handling damage as the complaint was caused by handling of the device or portion of the device without direct patient contact.(b)(4).

Event Description

It was reported that sterility was compromised.During unpacking of a 2.75mm x 12mm nc emerge balloon catheter, it was noted that there was a dirt on the back of compliance chart in the sterile pouch.The device was used without issue and the procedure was completed.No patient complications were reported.

• Brand Name: NC EMERGE®
• Type of Device: CATHETERS, TRANSLUMINAL CORONARY ANGIOPLASTY, PERCUTANEOUS
• Manufacturer (Section D): BOSTON SCIENTIFIC - MAPLE GROVE; one scimed place; maple grove MN 55311
• MDR Report Key: 7742646
• MDR Text Key: 115812440
• Report Number: 2134265-2018-06950
• Device Sequence Number: 1
• Product Code: LOX
• Combination Product (y/n): N
• PMA/PMN Number: SIMILAR
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 07/11/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/02/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 01/22/2020
• Device Model Number: H7493927612270
• Device Catalogue Number: 39276-1227
• Device Lot Number: 21640200
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/26/2018
• Date Manufacturer Received: 09/11/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1