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

Model Number H7493919312250

Device Problem Device Markings/Labelling Problem (2911)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 11/30/2016

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Device evaluated by mfr: the device has not been received for analysis.Upon receipt and completion of the failure analysis of the complaint device, if there is any further relevant information from that review, a supplemental medwatch will be filed.(b)(4).

Event Description

It was reported that the balloon markers were misaligned.The patient presented with inferior st elevation myocardial infarction (stemi).A 2.50mm x 12mm emerge¿ balloon catheter was selected to dilate the lesion.While the device was being placed, it was noticed that the balloon dilatation markers were incorrectly positioned.The procedure was completed with a different device.No patient complications were reported.

Manufacturer Narrative

Device evaluated by mfr: returned product consisted of an emerge balloon catheter device.The balloon was loosely folded and there was contrast in the balloon and inflation lumen.The balloon, markerbands, shaft and hypotube were microscopically and tactile inspected.Inspection revealed numerous kinks in the hypotube and a kink on the proximal end of the port/exit notch.Inspection of the markerbands revealed that they were placed 7mm and 13mm (respectively), and the proximal markerband appears slightly loose on the inner shaft (wire lumen).Inspection of the remainder of the device revealed no other damage or irregularities.Device analysis determined the condition of the returned device was consistent with the reported information.The manufacturing batch record review confirmed that the device met all material, assembly and performance specifications.The root cause has been determined to be manufacturing related.(b)(4).

Event Description

It was reported that the balloon markers were misaligned.The patient presented with inferior st elevation myocardial infarction (stemi).A 2.50mm x 12mm emerge¿ balloon catheter was selected to dilate the lesion.While the device was being placed, it was noticed that the balloon dilatation markers were incorrectly positioned.The procedure was completed with a different device.No patient 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: sonali arangil ; one scimed place; maple grove, MN 55311 ; 7634941700
• MDR Report Key: 6186723
• MDR Text Key: 62791345
• Report Number: 2134265-2016-11942
• Device Sequence Number: 1
• Product Code: LOX
• Combination Product (y/n): N
• Reporter Country Code: FR
• PMA/PMN Number: K113220
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Pharmacist
• Type of Report: Initial,Followup
• Report Date: 12/08/2016

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
• Device Operator: Health Professional
• Device Expiration Date: 11/30/2018
• Device Model Number: H7493919312250
• Device Catalogue Number: 39193-1225
• Device Lot Number: 19106071
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/20/2017
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 12/08/2016
• Initial Date FDA Received: 12/19/2016
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 04/11/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/05/2016
• 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
• Patient Age: 55 YR