FORCEP BIO/105/1.8/STR/ ENDOMYOCARDIAL BIOPSY

Additional Manufacturer Narrative

A REVIEW OF THE DEVICE BATCH RECORD BY LAKE REGION MEDICAL (CONTRACT MANUFACTURER) FOR THE BIOPSY FORCEPS WAS PERFORMED FOR RAW MATERIALS, IN-PROCESS AND FINISHED GOODS AND THERE WERE NO NON-CONFORMANCES OR CAPAS OPENED FOR SIMILAR COMPLAINTS. THE DEVICE MET ALL RAW MATERIALS, IN-PROCESS, AND FINISHED GOODS SPECIFICATIONS. PER THE COMPLAINANT, ST. JUDE FAST CATH INTRODUCER 7F X 98 CM WAS USED AT THE TIME OF THE EVENT. THIS NOT AN ARGON MEDICAL DEVICE PRODUCT; THEREFORE THE BATCH RECORD FOR THIS PRODUCT WAS NOT AVAILABLE FOR REVIEW. IT WAS STATED BY THE COMPLAINANT THAT THERE WAS A CRACK AND TIGHTENING OF THE TIP END OF THE INTRODUCER SHEATH (ST. JUDE) WITH THE RESULT OF PERFORATION OF THE INFERIOR VENA CAVA. THE REPORTED PERFORATION OF THE INFERIOR VENA CAVA MAY HAVE BEEN CAUSED BY THE ST. JUDE INTRODUCER SHEATH. HOWEVER, WITHOUT EITHER DEVICE, THE ROOT CAUSE OF THE PERFORATION IS NOT CERTAIN. PER THE COMPLAINT, A SORT OF RESISTANCE (TIGHTENING) WAS EXPERIENCED AT THE INTRODUCER SHEATH TIP WHEN THE BIOPSY FORCEP WAS INSERTED. THIS MAY BE AN INDICATION OF DEVICE INCOMPATIBILITY (UNDERSIZED SHEATH TIP) OR AN ATTEMPT TO OPEN THE JAWS WHEN STILL INSIDE OF THE INTRODUCER SHEATH. THE IFU STATES, "THE JAWS OF THE BIOPSY FORCEPS SHOULD BE OPENED AS THE FORCEP EMERGES FROM THE DISTAL END OF THE LONG SHEATH INTRODUCER OR GUIDING CATHETER." THERE HAVE BEEN NO OTHER SIMILAR COMPLAINTS RECEIVED FOR THIS PRODUCT.

Description of Event or Problem

PATIENT WAS UNDERGOING ENDOMYOCARDIAL BIOPSY VIA THE FEMORAL VEIN ACCESS. DURING REMOVAL OF THE ARGON JAWZ BIOPSY FORCEPS (1.8 X 105 CM) WHILE COLLECTING ADDITIONAL BIOPSY CUTTINGS, THE TIP END OF THE INTRODUCER SHEATH ( A FAST-CATH HEMOSTASIS 7F, 98CM MADE BY ST. JUDE MEDICAL) CRACKED AND TIGHTENED. THIS RESULTED IN A PERFORATION OF THE INFERIOR VENA CAVA WITH SIGNIFICANT BLEEDING. PATIENT REQUIRED A SURGICAL PROCEDURE TO REPAIR THE PERFORATION OF THE INFERIOR VENA CAVA. AS PART OF THE ORIGINAL TREATMENT PLAN, THE PATIENT ALSO RECEIVED A HEART TRANSPLANT. THE PATIENT IS IN STABLE CONDITION FOLLOWING THE REPAIR OF THE INFERIOR VENA CAVA, AND AFTER RECEIVING THE HEART TRANSPLANT.