FDA Adverse Event Injury Summary report: N

SPECTRANETICS LASER SHEATH

MDR report key: 1744573 · Received June 30, 2010

Report

Report Number: 1721279-2010-00044
Event Type: Injury
Date Received: June 30, 2010
Date of Event: January 1, 2008
Report Date: June 25, 2010
Manufacturer: SPECTRANETICS CORP.
Product Code: MFA
Adverse Event: Yes
Report Source: Manufacturer report
Reporter Location: CA
Reporter Occupation: PHYSICIAN

Narratives

Additional Manufacturer Narrative · 1

THE VIEWS AND CONCLUSIONS PRESENTED IN THIS JOURNAL ARTICLE DO NOT NECESSARILY REFLECT THOSE OF THE SPECTRANETICS CORPORATION. NO DEVICES FROM THE CASE WERE RETURNED FOR INVESTIGATIVE ANALYSIS, NOR WERE ANY ADDITIONAL CASE DETAILS PROVIDED FOR AN INTERNAL EVALUATION.

Description of Event or Problem · 1

THIS IS #5 OF SIX JOURNAL ARTICLES FOUND DURING A ROUTINE CLINICAL LITERATURE REVIEW. "ARTERIOVENOUS FISTULA AFTER LASER-ASSISTED EXTRACTION OF AN IMPLANTABLE DEFIBRILLATOR LEAD". JOURNAL: INTERACTIVE CARDIOVASCULAR AND THORACIC SURGERY 8(2009) 243-244. PATIENT WAS (B)(6) MALE PRESENTING WITH AN ACUTE AICD POCKET INFECTION. MD USED A 14F SLS TO LASE THE ATRIAL LEAD WITHOUT DIFFICULTY. THE VENTRICULAR LEAD WAS DIFFICULT TO PROGRESS PAST THE INNOMINATE VEIN AND SVC. AFTER SEVERAL ATTEMPTS, THE MD ABANDONED THE EXTRACTION. THE PATIENT TOLERATED THE PROCEDURE WELL AND A NEW DEVICE WAS IMPLANTED IN THE CONTRALATERAL SIDE AFTER COMPLETING A COURSE OF ANTIBIOTICS. PATIENT RETURNED COMPLAINING OF DYSPNEA AND FATIGUE. FURTHER TESTING REVEALED A AV FISTULA BETWEEN THE LEFT COMMON CAROTID ARTERY AND THE LEFT SUBCLAVIAN VEIN. THE PATIENT UNDERWENT A SUCCESSFUL STENT INSERTION TO OCCLUDE THE AV FISTULA.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
1	SPECTRANETICS LASER SHEATH	14F SLS	MFA	SPECTRANETICS CORP.	500-012	UNK

Patients

Seq	Age	Sex	Outcome	Treatment
1	78 YR		Required Intervention	SPECTRANETICS CVX-300 LASER