SPECTRANETICS LASER SHEATH

Report

Report Number: 1721279-2010-00043
Event Type: Injury
Date Received: June 30, 2010
Date of Event: January 1, 2005
Report Date: June 30, 2010
Manufacturer: SPECTRANETICS CORP.
Product Code: MFA
Adverse Event: Yes
Report Source: Manufacturer report
Reporter Location: NY, US
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 #4 OF SIX JOURNAL ARTICLES FOUND DURING A ROUTINE CLINICAL LITERATURE REVIEW. "ARTERIOVENOUS FISTULA AFTER LASER-ASSISTED PACEMAKER LEAD EXTRACTION". JOURNAL: THE ANNALS OF THORACIC SURGERY 2006;81:2304-6. PATIENT WAS A (B)(6) MALE WITH A HISTORY OF A-FIB AND A DUAL CHAMBER PACEMAKER (IMPLANTED 1995), PRESENTED WITH AN EROSION OF THE GENERATOR THROUGH THE SKIN. MD USED A 16F SLS TO EXTRACT THE VENTRICULAR LEAD WITHOUT DIFFICULTY. BECAUSE THE ATRIAL LEAD HAD PRE-OPERATIVE INTEGRITY PROBLEMS, UPON EXTRACTION, IT FRACTURED INTRAVASCULARLY. A TRANSFEMORAL APPROACH WAS USED TO REMOVE THE REMAINDER OF THE ATRIAL LEAD SUCCESSFULLY. THE PATIENT WAS DISCHARGED AND RETURNED A WEEK LATER FOR A CONTRALATERAL IMPLANTATION OF A NEW PACEMAKER. TWO WEEKS POST-OP, PATIENT RETURNED COMPLAINING OF INCREASED DYSPNEA AND WAS FOUND TO HAVE SIGNIFICANT JVD. AFTER A SERIES OF DIAGNOSTIC TESTING, THE PATIENT WAS FOUND TO HAVE AN AV FISTULA FROM THE LEFT COMMON CAROTID ARTERY TO THE INNOMINATE VEIN. PATIENT UNDERWENT AN OPEN-CHEST REPAIR, RECOVERED AND WAS DISCHARGED WITH NO COMPLICATIONS.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
1	SPECTRANETICS LASER SHEATH	16F SLS	MFA	SPECTRANETICS CORP.	500-013	UNK

Patients

Seq	Age	Sex	Outcome	Treatment
1	84 YR		Required Intervention	SPECTRANETICS CVX-300 LASER