FDA Adverse Event Malfunction Summary report: N

EMERGE¿

MDR report key: 2880247 · Received December 19, 2012

Report

Report Number: 2134265-2012-08130
Event Type: Malfunction
Date Received: December 19, 2012
Date of Event: November 22, 2012
Report Date: November 29, 2012
Manufacturer: BOSTON SCIENTIFIC - MAPLE GROVE
Product Code: LOX
PMA / PMN Number: K113220
Product Problem: Yes
Report Source: Manufacturer report
Reporter Location: CH
Reporter Occupation: PHYSICIAN

Narratives

Additional Manufacturer Narrative · 1

(B)(4). DEVICE EVALUATED BY MFR: 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).

Additional Manufacturer Narrative · 1

(B)(4).

Description of Event or Problem · 1

DURING A PERCUTANEOUS CORONARY INTERVENTION (PCI) PROCEDURE, MARKER BANDS WERE REPORTED AS MALPOSITIONED ON THE CATHETER. WHILE INFLATING THE BALLOON EMERGE, THE PHYSICIAN NOTICED THAT THE MARKERS INSIDE THE BALLOON WERE POSITIONED "TOO MUCH INSIDE THE BALLOON". NO PATIENT COMPLICATIONS WERE REPORTED AND THE PATIENT'S STATUS IS STABLE.

Description of Event or Problem · 1

IT WAS FURTHER REPORTED THAT THE LESION BEING TREATED WAS LOCATED IN THE LEFT ANTERIOR DESCENDING ARTERY (LAD). THE MARKERS LOOK LIKE AS IF THEY ARE NOT AT THE SHOULDERS, BUT FURTHER INSIDE THE BALLOON (MORE TOWARDS THE MIDDLE). THEY DID NOT MOVE, THEY JUST SEEM AT THE WRONG PLACE.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
1	EMERGE¿	CATHETERS, TRANSLUMINAL CORONARY ANGIOPLASTY, PERCUTANEOUS	LOX	BOSTON SCIENTIFIC - MAPLE GROVE	H7493919312350	15389411

Patients

Seq	Age	Sex	Outcome	Treatment
1	63 YR