| Seq | Brand | Generic | Manufacturer | Product code | Model | Catalog | Lot | PMA | 510(k) | Implant | Evaluated | Availability |
|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 1 | COOK CHORIONIC VILLUS SAMPLING SET | CATHETER, SAMPLING, CHORIONIC VILLUS | COOK UROLOGICAL INC. | LLX | NA | J-CVS-572700 | U2346485 | R | Y |
| Sequence | Received | Treatment | Outcome |
|---|---|---|---|
| 1 | 2015-02-11 | 0 |
Patient 1
DURING A PROCEDURE THAT OCCURRED 8 OR 9 MONTHS AGO, A RUPTURE OCCURRED CAUSING THE PT TO LOSE HER FETUS. THE PROVIDER AND STAFF COULD NOT DETERMINE WHAT CAUSED THE RUPTURE. THE STAFF IS CONCERNED THAT THE COOK CATHETER COULD BE A POSSIBLE CAUSE BUT COULD NOT BE CONFIRMED.
Patient 1
FETUS LOST IS NOT LABELED. BURST IN ASSOCIATION TO RUPTURE IS NOT LABELED. THE EVENT IS CURRENTLY UNDER INVESTIGATION. MORE INFO WILL BE PROVIDED UPON CONCLUSION.
Patient 1
THE ACTUAL COMPLAINT DEVICE WAS NOT RETURNED TO ASSIST IN THE INVESTIGATION, HOWEVER, FIVE UNOPENED, UNUSED DEVICES WERE RETURNED. A DIMENSIONAL VERIFICATION, FUNCTIONAL TEST, INSPECTION OF UNUSED PRODUCT, PERSONNEL INTERVIEW, ALONG WITH A REVIEW OF THE COMPLAINT HISTORY, DEVICE HISTORY RECORD, DRAWING, INSTRUCTIONS FOR USE (IFU), MANUFACTURING INSTRUCTIONS (MI), QUALITY CONTROL (QC), SPECIFICATIONS AND A VISUAL INSPECTION WAS CONDUCTED DURING OUR INVESTIGATION. THE 5 UNOPENED, UNUSED PRODUCTS WERE EXAMINED VISUALLY, DIMENSIONALLY AND UNDER MICROSCOPIC VISION PER THE MANUFACTURING AND QUALITY CONTROL SPECIFICATIONS, THIS PRODUCT IS INSPECTED 100%, ENSURING THE TRANSITION BETWEEN THE CATHETER AND OBTURATOR IS SMOOTH, ENSURING THE TIP IS ROUND AND SMOOTH, WITH NO TAPER AND THAT THE DEVICE IS FREE OF NICKS, DEBRIS AND DISCOLORATION. THE DEVICE HISTORY RECORD WAS REVIEWED AND THERE WAS NO INDICATION OF ANY NONCONFORMANCE PRESENT ON THE DOCUMENTATION. TWO INSTRUCTIONS FOR USE (IFU'S) ARE PROVIDED WITH THIS PRODUCT: THE PROFESSIONAL LABELING AND DIRECTIONS FOR USE, AND, THE PATIENT INFORMATION, WHERE INFORMATION IS PROVIDED THAT THERE IS ALWAYS A RISK OF MISCARRIAGE EVEN IF CVS IS NOT DONE. PER THE INSTRUCTIONS FOR USE, IT IS STATED- "ADVERSE EFFECTS OCCURRING IN THE COOK CVS CLINICAL STUDY IN THE 4363 PATIENTS WITH LONG TERM FOLLOW-UP DATA INCLUDE THE FOLLOWING 1-SPONTANEOUS ABORTION- SPONTANEOUS ABORTION WAS REPORTED IN 163 OF 4363 PATIENTS AVAILABLE FOR FOLLOW UP (3.7%) THIS ADVERSE EFFECT CAN POTENTIALLY BE MINIMIZED BY ULTRASOUND EXAMINATION IMMEDIATELY PRIOR TO THE PROCEDURE TO ENSURE VIABILITY OF THE PREGNANCY AND BY UTILIZING SAFE SAMPLING TECHNIQUES ADDITIONALLY, THIS RISK CAN BE MINIMIZED BY USING A NEW STERILE CATHETER FOR EACH CERVICAL OS PASS AND BY MAKING A MAXIMUM OF TWO PASSAGES THROUGH THE OS PER PREGNANCY IN ORDER TO ATTEMPT TO OBTAIN THE TISSUE SAMPLE." IT ALSO LISTS A POTENTIAL ADVERSE EVENT AS "INTRAUTERINE DEATH- AN INCREASED RISK OF INTRAUTERINE DEATH IS KNOWN TO BE ASSOCIATED WITH SIGNIFICANT INTERRUPTION OF THE FETAL BLOOD SUPPLY BY CHORIONIC (PLACENTAL) DAMAGE OR INTRAUTERINE INFECTION ADHERENCE TO CVS SAFETY PROCEDURES WILL MINIMIZE THE POTENTIAL RISK IN TERMS OF THE PROCEDURE." THE IFU INSTRUCTS PHYSICIANS, IN BOLD PRINT "THE ULTRASOUND MEASUREMENT SHOULD PROVIDE THE DISTANCE FROM THE INTERNAL OS TO THE SAMPLING SITE AND HELP DETERMINE THE OPTIMAL CURVE, IF ANY, REQUIRED FOR THE ASSEMBLED CATHETER AND STYLET THAT WILL BE USED FOR SAMPLING " LATER IN THE IFU IT INSTRUCTS "SLOWLY INSERT THE CATHETER THROUGH THE ENDOCERVIX TO THE SAMPLING SITE UNDER ULTRASOUND GUIDANCE. CARE MUST BE TAKEN TO AVOID ENTERING THE AMNIOTIC SAC." THE FINAL STATEMENT IN THE IFU, "NOTE: IT IS IMPORTANT THAT NO CATHETER BE PASSED THROUGH THE CERVICAL OS MORE THAN ONE TIME AND THAT NO MORE THAN TWO CATHETER PASSES BE MADE THROUGH THE CERVICAL OS PER PREGNANCY. MAKING THREE OR MORE PASSES THROUGH THE CERVICAL OS HAS BEEN ASSOCIATED WITH A SIGNIFICANTLY INCREASED RISK OF PREGNANCY LOSS." REQUESTS FOR ADDITIONAL PATIENT AND PROCEDURE INFORMATION HAVE BEEN MADE WITH NO SUCCESS. THIS DEVICE IS INTENDED TO OBTAIN CHORIONIC TISSUE SAMPLES TRANSCERVICALLY FOR THE PURPOSE OF PRENATAL DIAGNOSIS OF GENETIC ABNORMALITIES DURING WEEKS 10-12 OF PREGNANCY. THERE ARE A MULTITUDE OF RISKS ASSOCIATED WITH THE PROCEDURES, WHICH ARE THOROUGHLY OUTLINED IN BOTH THE PROFESSIONAL LABELING AND DIRECTIONS FOR USE AND THE PATIENT INFORMATION. BASED ON THE INFORMATION PROVIDED, WE ARE UNABLE TO DETERMINE A DEFINITIVE ROOT CAUSE FOR THE EXPERIENCED DIFFICULTY. THE APPROPRIATE INTERNAL PERSONNEL HAVE BEEN NOTIFIED AND WE WILL CONTINUE TO MONITOR THIS DEVICE. PER THE QUALITY ENGINEERING RISK ASSESSMENT (QERA), NO FURTHER ACTION WILL BE REQUIRED AT THIS TIME.
Patient 1
DURING A CHRONIC VILLUS SAMPLING PROCEDURE THAT OCCURRED 8 OR 9 MONTHS AGO, A RUPTURE OCCURRED CAUSING THE PATIENT TO LOSE HER FETUS. THE PROVIDER AND STAFF COULD NOT DETERMINE WHAT CAUSED THE RUPTURE. THE STAFF IS CONCERNED THAT THE COOK CATHETER COULD BE A POSSIBLE CAUSE BUT COULD NOT BE CONFIRMED. ALTHOUGH REQUESTED, NO ADDITIONAL INFORMATION HAS BEEN PROVIDED REGARDING PATIENT OUTCOME.