FLEXTEND

Report

Report Number: 2124215-2014-10838
Event Type: Injury
Date Received: July 1, 2014
Date of Event: March 17, 2014
Report Date: September 22, 2014
Manufacturer: CPI - DEL CARIBE
Product Code: DTB
Adverse Event: Yes
Product Problem: Yes
Report Source: Manufacturer report
Reporter Occupation: PHYSICIAN

Narratives

Additional Manufacturer Narrative · 1

(B)(4).

Additional Manufacturer Narrative · 1

(B)(4). UPON RETURN, THE PRODUCT WAS ANALYZED. VISUAL INSPECTION CONFIRMED A COMPLETE LEAD WITH AN EXTENDED HELIX. ADDITIONALLY, DRIED BLOOD WAS NOTED IN AND AROUND THE HELIX HOUSING; TISSUE ENTWINED WITHIN THE HELIX COIL. THE HELIX WAS FUNCTIONALLY TESTED; HOWEVER, DUE TO THE ENTWINED TISSUE AND BLOOD INFILTRATION, DEEMED NON-FUNCTIONAL. NO MANUFACTURING ANOMALIES WERE OBSERVED DURING THE ANALYSIS PROCESS AND NO FURTHER TESTING WAS PERFORMED. AS OBSERVED IN THE LABORATORY, AN EXTENDABLE/RETRACTABLE HELIX LEAD IS SUSCEPTIBLE TO BLOOD INFILTRATION. ONCE THIS HAS OCCURRED, EXTENSION/RETRACTION OF HELIX MAY NO LONGER FUNCTION AS DESIGNED. ANALYSIS WAS UNABLE TO ASSOCIATE THE REPORTED ALLEGATION TO ANY PRODUCT MALFUNCTION.

Additional Manufacturer Narrative · 1

(B)(4). FOLLOWING RETURN AND COMPLETION OF LABORATORY ANALYSIS, THIS EVENT WILL BE FURTHER UPDATED.

Description of Event or Problem · 1

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Description of Event or Problem · 1

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Description of Event or Problem · 1

BOSTON SCIENTIFIC RECEIVED INFORMATION THAT FOLLOWING A SUCCESSFUL RIGHT VENTRICULAR (RV) LEAD IMPLANT, THE PHYSICIAN DISCOVERED A PERFORATION VIA FLUOROSCOPY IMAGING. AS A RESULT, THE LEAD WAS EXPLANTED: EXPLANTED LEAD TO BE RETURNED FOR ANALYSIS. THE HELIX WAS THEN DEEMED NON-FUNCTIONAL AND ANOTHER BOSTON SCIENTIFIC RV LEAD IMPLANTED WITHOUT COMPLICATION. NO FURTHER ADVERSE PATIENT EFFECTS WERE REPORTED.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
382818	FLEXTEND	IMPLANTABLE LEAD	DTB	CPI - DEL CARIBE	4088

Patients

Seq	Age	Sex	Outcome	Treatment
1			Life Threatening\| R	4088\| K082