SOFT-PASS ECHOTIP EMBRYO TRANSFER CATHETER SET
Report
- Report Number
- 1820334-2020-01850
- Event Type
- Malfunction
- Date Received
- October 14, 2020
- Report Date
- September 8, 2021
- Manufacturer
- COOK INC
- Product Code
- MQF
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- OH, US
- Reporter Occupation
- OTHER
Narratives
CORRECTED INFORMATION: G4: PMA/510(K) NUMBER = K173103. THIS INFORMATION WAS AVAILABLE, HOWEVER WAS INADVERTENTLY OMITTED FROM PREVIOUSLY SUBMITTED REPORTS. THIS REPORT IS REQUIRED BY THE FDA UNDER 21 CFR PART 803 AND IS BASED ON UNCONFIRMED INFORMATION SUBMITTED BY OTHERS. NEITHER THE SUBMISSION OF THIS REPORT NOR ANY STATEMENT CONTAINED HEREIN IS INTENDED TO BE AN ADMISSION THAT ANY COOK DEVICE IS DEFECTIVE OR MALFUNCTIONED, THAT A DEATH OR SERIOUS INJURY OCCURRED, NOR THAT ANY COOK DEVICE CAUSED, CONTRIBUTED TO, OR IS LIKELY TO CAUSE OR CONTRIBUTE TO A DEATH OR SERIOUS INJURY IF A MALFUNCTION OCCURRED.
BLANK FIELDS ON THIS FORM INDICATE THE INFORMATION IS UNCHANGED, UNKNOWN OR UNAVAILABLE. EVENT DESCRIPTION COOK WAS INFORMED OF AN INCIDENT INVOLVING A SOFT-PASS ECHOTIP EMBRYO TRANSFER CATHETER SET WITH RPN K-J-SPPE-681710-ET FROM AN UNKNOWN LOT NUMBER. THE CUSTOMER REPORTED THERE WAS A HARD PIECE OF COILED UP PLASTIC INSIDE THE TIP OF THE CATHETER ON AN UNKNOWN DATE. FURTHER COMMUNICATION WITH THE CUSTOMER CLARIFIED THE FOLLOWING: WHEN LOADING THE EMBRYO INTO THE TIP OF THE CATHETER, THERE WAS A HARD PIECE OF COILED UP PLASTIC INSIDE THE TIP OF THE CATHETER. I COULD NOT DISLODGE THE PIECE AND IT WOULD HAVE AFFECTED THE EMBRYOS LOADING AND UNLOADING OF THE CATHETER HAD I TRIED ANY HARDER. NONE OF THE EMBRYOS WERE RUINED. THERE WERE NO PHOTOS AVAILABLE. THE COLOR OF THE PLASTIC IS UNKNOWN. THE CUSTOMER USED ANOTHER CATHETER TO CONTINUE WITH THE PROCEDURE. THERE WERE NO ADVERSE EFFECTS REPORTED AS A RESULT OF THIS ISSUE. INVESTIGATION - EVALUATION A DOCUMENT-BASED INVESTIGATION WAS PERFORMED INCLUDING A REVIEW OF MANUFACTURING INSTRUCTIONS, INSTRUCTIONS FOR USE (IFU), SPECIFICATIONS, AND QUALITY CONTROL DATA. THE COMPLAINT DEVICE WAS NOT RETURNED; THEREFORE, NO PHYSICAL EXAMINATIONS COULD BE PERFORMED. THERE IS NO EVIDENCE TO SUGGEST THE PRODUCT WAS NOT MADE TO SPECIFICATIONS. BECAUSE PRODUCTION LOT INFORMATION WAS NOT PROVIDED, NO REPRESENTATIVE PRODUCT FROM THE PRODUCTION LOT COULD BE EVALUATED. REVIEWS OF THE DEVICE HISTORY RECORD AND COMPLAINT HISTORY COULD NOT BE COMPLETED DUE TO LACK OF INFORMATION FROM THE USER FACILITY. COOK ALSO REVIEWED PRODUCT LABELING. THE PRODUCT IFU, T_K-J-ETC_REV2 ¿EMBRYO TRANSFER CATHETER,¿ DOES NOT PROVIDE ANY INFORMATION FOR END USERS RELATED TO THIS FAILURE MODE. SINCE THE DEVICE WAS NOT RETURNED, SUFFICIENT CONTROLS WERE IDENTIFIED, AND NO PRODUCTION LOT NUMBER COULD BE PROVIDED BY THE COMPLAINANT, THE SOURCE OF THE FOREIGN MATTER COULD NOT BE DETERMINED. THE AVAILABLE EVIDENCE SUGGESTS THE DEVICE WAS MANUFACTURED TO SPECIFICATIONS. COOK WILL CONTINUE OUR MONITORING OF SIMILAR COMPLAINTS AND HAVE NOTIFIED THE APPROPRIATE PERSONNEL OF THIS EVENT. THIS REPORT IS REQUIRED BY THE FDA UNDER 21 CFR PART 803. THIS REPORT IS BASED ON UNCONFIRMED INFORMATION SUBMITTED BY OTHERS. NEITHER THE SUBMISSION OF THIS REPORT NOR ANY STATEMENT MADE IN IT IS INTENDED TO BE AN ADMISSION THAT ANY COOK DEVICE IS DEFECTIVE OR MALFUNCTIONED; THAT A DEATH OR SERIOUS INJURY OCCURRED; OR THAT ANY COOK DEVICE CAUSED OR CONTRIBUTED TO; OR IS LIKELY TO CAUSE OR CONTRIBUTE TO A DEATH OR SERIOUS INJURY IF A MALFUNCTION OCCURRED.
BLANK FIELDS ON THIS FORM INDICATE THE INFORMATION IS UNKNOWN, UNAVAILABLE, OR UNCHANGED. THE EVENT IS CURRENTLY UNDER INVESTIGATION. A FOLLOW-UP REPORT WILL BE SUBMITTED UPON RECEIPT OF ADDITIONAL INFORMATION OR COMPLETION OF THE INVESTIGATION. THIS REPORT IS REQUIRED BY THE FDA UNDER 21 CFR PART 803. THIS REPORT IS BASED ON UNCONFIRMED INFORMATION SUBMITTED BY OTHERS. NEITHER THE SUBMISSION OF THIS REPORT NOR ANY STATEMENT MADE IN IT IS INTENDED TO BE AN ADMISSION THAT ANY COOK DEVICE IS DEFECTIVE OR MALFUNCTIONED; THAT A DEATH OR SERIOUS INJURY OCCURRED; OR THAT ANY COOK DEVICE CAUSED OR CONTRIBUTED TO; OR IS LIKELY TO CAUSE OR CONTRIBUTE TO A DEATH OR SERIOUS INJURY IF A MALFUNCTION OCCURRED.
NO ADDITIONAL INFORMATION REGARDING THE PATIENT AND/OR EVENT HAS BEEN RECEIVED SINCE THE PREVIOUS MEDWATCH REPORT WAS SENT.
NO NEW PATIENT OR EVENT INFORMATION SINCE THE LAST REPORT WAS SUBMITTED.
ADDITIONAL INFORMATION PROVIDED ON 14OCT2020. NONE OF THE EMBRYOS WERE RUINED. A NEW CATHETER WAS USED TO CONTINUE THE PROCEDURE.
OCCUPATION: EMBRYOLOGIST. THIS REPORT INCLUDES INFORMATION KNOWN AT THIS TIME. A FOLLOW UP REPORT WILL BE SUBMITTED SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE.
IT WAS REPORTED, WHEN LOADING THE EMBRYO INTO THE TIP OF THE CATHETER, THERE WAS A HARD PIECE OF COILED UP PLASTIC INSIDE THE TIP OF THE CATHETER. THE HARD PIECE OF PLASTIC COULD NOT BE DISLODGED AND "IT WOULD HAVE AFFECTED THE EMBRYOS LOADING AND UNLOADING OF THE CATHETER HAD I TRIED ANY HARDER". THE DEVICE WAS REPORTED TO BE A COOK EMBRYO TRANSFER CATHETER, BUT THE CATALOG NUMBER OR LOT NUMBER WERE NOT PROVIDED. NO ADVERSE EVENTS HAVE BEEN REPORTED AS A RESULT OF THE ALLEGED MALFUNCTION. ADDITIONAL INFORMATION HAS BEEN REQUESTED REGARDING THE PATIENT AND THE EVENT. AT THE TIME OF THIS REPORT, NO FURTHER INFORMATION HAS BEEN PROVIDED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1141953 | SOFT-PASS ECHOTIP EMBRYO TRANSFER CATHETER SET | MQF CATHETER, ASSISTED REPRODUCTION | MQF | COOK INC | UNKNOWN |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |