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

Model Number H7493919308120

Device Problem Contamination /Decontamination Problem (2895)

Patient Problem No Patient Involvement (2645)

Event Type  malfunction  

Manufacturer Narrative

(b)(4).(b)(6).Device evaluated by manufacturer: it is indicated that the device will not be returned for evaluation; therefore a failure analysis of the complaint device could not be completed.The batch number is unknown and the manufacturing records for the complaint device could not be reviewed.The most probable root cause is considered user preference issue as the product met specification but the user was reportedly dissatisfied with the function, performance, or appearance of the product.(b)(4).

Event Description

It was reported that product sterility was compromised.The emerge balloon catheters are packaged in a way that upon opening, they jump from the sterile inner package to the unsterile outer package, becoming contaminated.This happens outside of the patient during preparation, with no patient contact.No complications were reported.

• Brand Name: EMERGE¿
• Type of Device: CATHETERS, TRANSLUMINAL CORONARY ANGIOPLASTY, PERCUTANEOUS
• Manufacturer (Section D): BOSTON SCIENTIFIC - MAPLE GROVE; one scimed place; maple grove MN 55311
• Manufacturer Contact: linda leimer ; one scimed place; maple grove, MN 55311 ; 7634941700
• MDR Report Key: 5893259
• MDR Text Key: 52660513
• Report Number: 2134265-2016-07278
• Device Sequence Number: 1
• Product Code: LOX
• Combination Product (y/n): N
• PMA/PMN Number: K113220
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Health Professional
• Type of Report: Initial
• Report Date: 07/25/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/22/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: H7493919308120
• Device Catalogue Number: 39193-0812
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 07/25/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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