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

Model Number H7493927612200

Device Problems Break (1069); Material Rupture (1546)

Patient Problem Death (1802)

Event Date 06/29/2018

Event Type  Death  

Manufacturer Narrative

(b)(4).Device evaluated by mfr.: it is indicated that the device will not be returned for evaluation.If there is any further relevant information obtained, a supplemental mdr will be filed   (b)(4).

Event Description

Same case as mdr id: 2134265-2018-06546.It was reported that the patient died.The patient presented with acute myocardial infarction and acute pulmonary edema.A 2.00mm x 12mm nc emerge® balloon catheter was advanced for treatment.However, during dilatation, the balloon ruptured.Subsequently, the device was replaced with a 2.50mm x 12mm nc emerge® balloon catheter which also ruptured and upon withdrawal, the shaft broke.The device was removed; however, it was noted that the left anterior descending artery flow had decreased.The patient had cardiac arrest and died.The physician assessed that the event is unrelated to the devices and the possible contributing factor is other co-morbidity.

Manufacturer Narrative

(b)(4).

Event Description

Same case as mdr id: 2134265-2018-06546.It was reported that the patient died.The patient presented with acute myocardial infarction and acute pulmonary edema.A 2.00mm x 12mm nc emerge® balloon catheter was advanced for treatment.However, during dilatation, the balloon ruptured.Subsequently, the device was replaced with a 2.50mm x 12mm nc emerge® balloon catheter which also ruptured and upon withdrawal, the shaft broke.The device was removed; however, it was noted that the left anterior descending artery flow had decreased.The patient had cardiac arrest and died.The physician assessed that the event is unrelated to the devices and the possible contributing factor is other co-morbidity.

• 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
• Manufacturer Contact: sonali arangil ; one scimed place; maple grove, MN 55311 ; 7634941700
• MDR Report Key: 7707296
• MDR Text Key: 114605543
• Report Number: 2134265-2018-06545
• Device Sequence Number: 1
• Product Code: LOX
• Combination Product (y/n): N
• Reporter Country Code: IT
• PMA/PMN Number: SIMILAR
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 06/29/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/20/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 05/09/2020
• Device Model Number: H7493927612200
• Device Catalogue Number: 39276-1220
• Device Lot Number: 22100373
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 09/06/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/10/2018
• 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
• Patient Outcome(s): Death
• Patient Age: 98 YR