FDA Adverse Event Injury Summary report: N

AVX® THROMBECTOMY SET

MDR report key: 5360155 · Received January 12, 2016

Report

Report Number: 2134265-2016-00055
Event Type: Injury
Date Received: January 12, 2016
Date of Event: December 14, 2015
Report Date: December 14, 2015
Manufacturer: BOSTON SCIENTIFIC - MAPLE GROVE
Product Code: DXE
PMA / PMN Number: K133629
Adverse Event: Yes
Report Source: Manufacturer report
Reporter Location: NC, US
Reporter Occupation: PHYSICIAN

Narratives

Additional Manufacturer Narrative · 1

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. A REVIEW OF THE BATCH HISTORY, HISTORICAL TRENDING, AND SIMILAR COMPLAINT TRENDING REVIEW FOR THE PRODUCT FAMILY WILL BE CONDUCTED. IF THERE IS ANY FURTHER RELEVANT INFORMATION FROM THAT REVIEW, A SUPPLEMENTAL MEDWATCH WILL BE FILED. (B)(4).

Description of Event or Problem · 1

THE PROCEDURE WAS PERFORMED WITHOUT ANY INCIDENT USING A AVX® THROMBECTOMY SET. POST PROCEDURE, DURING TRANSPORTING THE PATIENT BACK, THE PATIENT EXPERIENCED LIGHTHEADEDNESS AND THOUGHT SHE WAS GOING TO PASS OUT, THEN HAD A SEIZURE LIKE ACTIVITY AND BECAME UNRESPONSIVE AND A CODE WAS CALLED. THE RESPONSE TEAM PERFORMED NORMAL PROTOCOL. THE PATIENT WAS DOING FINE.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
19244	AVX® THROMBECTOMY SET	CATHETER, EMBOLECTOMY	DXE	BOSTON SCIENTIFIC - MAPLE GROVE	105039-001	0000190362

Patients

Seq	Age	Sex	Outcome	Treatment
1			Required Intervention