POLYHESIVE PATIENT RETURN ELECTRODE

Report

Report Number: 3005099803-2010-04330
Event Type: Malfunction
Date Received: October 8, 2010
Date of Event: September 16, 2010
Report Date: September 16, 2010
Manufacturer: BOSTON SCIENTIFIC - MARLBOROUGH
Product Code: GEI
PMA / PMN Number: K822572
Product Problem: Yes
Report Source: Manufacturer report
Reporter Occupation: PHYSICIAN

Narratives

Additional Manufacturer Narrative · 1

ADDITIONAL INFORMATION - THIS REPORT WAS FILED IN ERROR. THIS REPORT WAS FILED SOLELY FOR GEL DISCOLORATION. PAD GEL DISCOLORATION ALONE IS NOT AN MDR-REPORTABLE SCENARIO. A VISUAL EXAMINATION OF THE RETURNED DEVICE FOUND DISCOLORATION AT THE BOTTOM LEFT OF THE PAD. NO OTHER PHYSICAL DEFECTS WERE OBSERVED. ADDITIONALLY, THE WIRES WERE SECURELY ATTACHED AND THE PAD PASSED A CONTINUITY TEST. THE CONDITION OF THE RETURNED INCIDENT DEVICE WAS CONSISTENT WITH THE COMPLAINT OF PAD DISCOLORATION. THIS EVENT IS CONSIDERED A USER PREFERENCE ISSUE. THE OEM INVESTIGATOR NOTED, "ON OCCASION, THE VALLEYLAB POLYHESIVE CONDUCTIVE ADHESIVE MAY HAVE AREAS OR SPOTS OF DISCOLORATION WITHIN THE GEL. THIS IS OF NO CLINICAL CONSEQUENCE. THE SMALL AREAS OF DISCOLORATION ON THE PADS ARE DUE TO TARNISH ON THE SURFACE OF THE CONDUCTIVE FOIL BENEATH THE POLYHESIVE MATERIAL. THE DISCOLORATION IS THE RESULT OF THE AQUEOUS ENVIRONMENT PROVIDED BY THE POLYHESIVE IN CONTACT WITH THE METAL FOIL. PAST INVESTIGATIONS HAVE DEMONSTRATED THAT DISCOLORATION DOES NOT AFFECT THE INTEGRITY OR SAFE USE OF THE PRODUCT." THUS, THE ISSUE OF PAD DISCOLORATION IS NOT CONSIDERED A MDR REPORTABLE EVENT. A REVIEW OF THE DEVICE HISTORY RECORD (DHR) WAS PERFORMED; NO ANOMALIES WERE NOTED. (B)(4).

Additional Manufacturer Narrative · 1

PATIENT IDENTIFIER, AGE/DATE OF BIRTH, GENDER, AND WEIGHT ARE UNKNOWN. THE DEVICE HAS BEEN RECEIVED FOR ANALYSIS. UPON COMPLETION OF THE FAILURE ANALYSIS OF THE COMPLAINT DEVICE, IF THERE IS ANY FURTHER RELEVANT INFORMATION FROM THAT REVIEW, A SUPPLEMENTAL MEDWATCH WILL BE FILED. (B)(4).

Additional Manufacturer Narrative · 1

THE OEM INVESTIGATOR NOTED, "ON OCCASION, THE VALLEYLAB POLYHESIVE CONDUCTIVE ADHESIVE MAY HAVE AREAS OR SPOTS OF DISCOLORATION WITHIN THE GEL. THIS IS OF NO CLINICAL CONSEQUENCE. THE SMALL AREAS OF DISCOLORATION ON THE PADS ARE DUE TO TARNISH ON THE SURFACE OF THE CONDUCTIVE FOIL BENEATH THE POLYHESIVE MATERIAL. THE DISCOLORATION IS THE RESULT OF THE AQUEOUS ENVIRONMENT PROVIDED BY THE POLYHESIVE IN CONTACT WITH THE METAL FOIL. PAST INVESTIGATIONS HAVE DEMONSTRATED THAT DISCOLORATION DOES NOT AFFECT THE INTEGRITY OR SAFE USE OF THE PRODUCT." THUS, THE ISSUE OF PAD DISCOLORATION IS NOT CONSIDERED A MDR REPORTABLE EVENT. (B)(4).

Description of Event or Problem · 1

IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A PATIENT RETURN GROUNDING PAD WAS USED DURING A RFA (RADIOFREQUENCY ABLATION) PROCEDURE PERFORMED ON (B)(6), 2010. ACCORDING TO THE COMPLAINANT, WHILE PREPARING FOR THE ABLATION, DISCOLORATION WAS NOTED ON ONE OF THE GROUNDING PADS. THE PROCEDURE WAS COMPLETED WITH ANOTHER PATIENT RETURN GROUNDING PAD. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT. THE PATIENT'S CONDITION AT THE CONCLUSION OF THE PROCEDURE WAS REPORTED TO BE GOOD. ATTEMPTS TO OBTAIN ADDITIONAL INFORMATION REGARDING THE CIRCUMSTANCES SURROUNDING THIS EVENT HAVE BEEN UNSUCCESSFUL TO DATE. SHOULD ADDITIONAL RELEVANT DETAILS BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

Description of Event or Problem · 1

IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A PATIENT RETURN GROUNDING PAD WAS USED DURING A RFA (RADIOFREQUENCY ABLATION) PROCEDURE PERFORMED ON (B)(6), 2010. ACCORDING TO THE COMPLAINANT, WHILE PREPARING FOR THE ABLATION, DISCOLORATION WAS NOTED ON ONE OF THE GROUNDING PADS. THE PROCEDURE WAS COMPLETED WITH ANOTHER PATIENT RETURN GROUNDING PAD. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT. THE PATIENT'S CONDITION AT THE CONCLUSION OF THE PROCEDURE WAS REPORTED TO BE GOOD. ATTEMPTS TO OBTAIN ADDITIONAL INFORMATION REGARDING THE CIRCUMSTANCES SURROUNDING THIS EVENT HAVE BEEN UNSUCCESSFUL TO DATE. SHOULD ADDITIONAL RELEVANT DETAILS BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

Description of Event or Problem · 1

IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A PATIENT RETURN GROUNDING PAD WAS USED DURING A RFA (RADIOFREQUENCY ABLATION) PROCEDURE PERFORMED ON (B)(6), 2010. ACCORDING TO THE COMPLAINANT, WHILE PREPARING FOR THE ABLATION, DISCOLORATION WAS NOTED ON ONE OF THE GROUNDING PADS. THE PROCEDURE WAS COMPLETED WITH ANOTHER PATIENT RETURN GROUNDING PAD. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT. THE PATIENT'S CONDITION AT THE CONCLUSION OF THE PROCEDURE WAS REPORTED TO BE GOOD. ATTEMPTS TO OBTAIN ADDITIONAL INFORMATION REGARDING THE CIRCUMSTANCES SURROUNDING THIS EVENT HAVE BEEN UNSUCCESSFUL TO DATE. SHOULD ADDITIONAL RELEVANT DETAILS BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
1	POLYHESIVE PATIENT RETURN ELECTRODE	ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES	GEI	BOSTON SCIENTIFIC - MARLBOROUGH	M001262191	151305

Patients

Seq	Age	Sex	Outcome	Treatment
1