FDA.reportPublic FDA data

MAUDE MDR 6546388

MDR report key
6546388
Report number
3008007615-2017-00001
Event key
0
Event type
3
Date of event
2016-11-13
Date received
2017-05-04
Adverse event
3
Product problem
3
Patients in event
0
Reporter occupation
1
Health professional
3
Initial report to FDA
3
Event location
3

Manufacturer Contact#

Contact
DR. KELLY CULWELL
Address
12400 HIGH BLUFF DRIVE SUITE 600 SAN DIEGO CA 92130 US
Phone
858-858-8583
Report source
M
Manufacturer link flag
Y

Devices#

Seq, Brand, Generic table
SeqBrandGenericManufacturerProduct codeModelCatalogLotPMA510(k)ImplantEvaluatedAvailability
1IPAS MANUAL VACUUM ASPIRATION (MVA); IPAS EASY GRIP CANNULAEVACUUM ABORTION SYSTEM; CANNULA-SUCTION, UTERINE, PRODUCT CODE: HHIWOMANCARE GLOBALHHIPLUSPLUSUNKNOWNR N

Patients#

Sequence, Received, Treatment table
SequenceReceivedTreatmentOutcome
12017-05-0401. R

Event Narratives#

N

Patient 1

ON 2017-02-16 - FOLLOW-UP INFORMATION REQUESTED TO/RECEIVED FROM USER SITE: PRODUCT INFORMATION: WCG: SPECIFIC DEVICES INVOLVED IN THE PROCEDURE - PART NUMBER AND/OR PRODUCT NAME OF ASPIRATOR AND CANNULA USED. USER SITE: I DO NOT HAVE THE DEVICE USED AT THAT TIME AND ALSO DO NOT HAVE A NUMBER TO BE RECORDED IN THE MEDICAL RECORD. USER SITE: THE IPAS AMEU PLUS ASPIRATOR AND THE IPAS EASY GRIP CANNULA ARE USED. WCG: ARE THESE DEVICES AVAILABLE FOR REVIEW? PHOTOS AVAILABLE FOR REVIEW? USER SITE: I DO NOT HAVE THE EQUIPMENT USED AT THAT TIME. WCG: STATUS OF DEVICE PRIOR TO USE. WCG: AGE OF DEVICES? USER SITE: THE DEVICES THAT THEY ARE USING WERE DELIVERED IN AUGUST AND SEPTEMBER AND WE USED THEM (APPROXIMATELY 3 MONTHS AT THAT TIME). WCG: ESTIMATED NUMBER OF USE OF EACH DEVICE PRIOR TO PROCEDURE (E.G. NEW, 50 TIMES)? USER SITE: USED DEVICES AND CANNULAS HAD APPROXIMATELY 25-50 USES. WCG: WAS PRODUCT STERILIZED AND/OR CLEANED PRIOR TO USE? IF YES - CAN YOU PLEASE DESCRIBE METHOD, EQUIPMENT, CHEMICALS USED? USER SITE: THE APPLIANCE WAS IN PERFECT CONDITION. USER SITE: CULTIVATION OF OTHER EQUIPMENT AFTER STYLIZATION WAS PERFORMED TO CONFIRM THE CONDITION AND THESE WERE NEGATIVE. WCG SITE: CONDITION OF DEVICES AFTER USE (E.G. BREAKS, BRITTLE, ETC.)? USER: THE DEVICE WAS IN PERFECT CONDITION. PATIENT/PROCEDURE INFORMATION: WCG: EXPERIENCE OF PRACTITIONER PERFORMING PROCEDURE (E.G. POSITION OF HEALTHCARE PROFESSIONAL AND NUMBER OF YEARS OF EXPERIENCE PERFORMING MVA PROCEDURE)? USER STIE: ALTHOUGH I AM DOING MVA SINCE 2015, I WAS TRAINED BY IPAS IN (B)(6) IN MAY 2016. WCG: DATE OF INITIAL MVA PROCEDURE PERFORMED? USER SITE: 11/13/2016 (**WCG NOTE: DATE PROVIDED WAS THE ACTUAL REPORTED DATE OF ADVERSE EVENT RATHER THAN DATE OF MVA PROCEDURE). WCG: GESTATIONAL AGE OF PREGNANCY? USER SITE: 8 WEEKS. WCG: WHAT TREATMENT/DIAGNOSTIC TESTING WAS PERFORMED PRIOR TO FIRST SURGERY (E.G. ANTIBIOTICS, ULTRASOUND, CT SCAN, X-RAY, REMOVAL OF IUD)? USER SITE: A GYNECOLOGICAL ULTRASOUND PRIOR TO ASPIRATION, AS WELL AS ANTIBIOTICS (AT THAT TIME WE USED CIPROFLOXACIN-METRONIDAZOLE VIA ORAL) WERE ALSO ADMINISTERED, THE PATIENT HAD NO IUD AT THE TIME OF SURGERY, WAS WITHDRAWN BEFORE IT. USER SITE: ALL HISTOPATHOLOGY RESULTS OBTAINED DID NOT SHOW MICROSCOPIC SIGNS OF INFECTION IN THE SUBMITTED PIECE (FALLOPIAN TUBE) AND ALL CULTURES WERE NEGATIVE. USER - COMMENT: FROM USER SITE INVESTIGATOR: AFTER ANALYZING THE CASE WITH THE HEAD OF THE GYNECOLOGICAL DEPARTMENT OF THE (B)(6) HOSPITAL, THEY CONSIDER THAT THE BEHAVIOR OF THE DOCTORS ON GUARD COULD BEEN BETTER. (WHICH IS ALSO MY OPINION) THEY SHOULD HAD ASKED FOR A SECOND OPINION OF THE CASE AND THEIR THERAPEUTIC BEHAVIOR WAS VERY AGGRESSIVE, INSTEAD WAITING THE CLINICAL RESPONSE AFTER REMOVAL THE IUD AND THE ANTIBIOTICS THE OB / GYN DEPARTMENT IS WORKING ON IMPROVING THIS ISSUE WITH THE MEDICAL STAFF OF THE HOSPITAL. WCG - COMMENT FROM WCG QA: FURTHER INVESTIGATION/EVALUATION OF THE REPORTED PLUS AND EASY GRIP CANNULA DEVICES USED IN THE MVA PROCEDURE COULD NOT BE PERFORMED AS LOT NUMBER INFORMATION COULD NOT BE PROVIDED. DEVICE WAS NOT AVAILABLE FOR EVALUATION.

D

Patient 1

ON 20 DECEMBER 2016 - INITIAL REPORT RECEIVED BY WCG: WOMANCARE GLOBAL WAS NOTIFIED BY A (B)(6) USER SITE OF THE IPAS MANUAL VACUUM ASPIRATOR (MVA) AND IPAS EASY GRIP REGARDING AN ADVERSE EVENT THAT OCCURRED POST MVA PROCEDURE ON (B)(6) 2016 WHICH INVOLVED AN UNINTENDED INTRA-ABDOMINAL SURGERY. THE ARGENTINA HEALTH PROFESSIONAL REPORTED THAT AN MVA PROCEDURE THAT USED THE WCG PLUS AND WCG EASY GRIP CANNULA WAS PERFORMED FOR A WOMAN WITH AN 8 WEEKS GESTATION. SHE HAD NO SIGNS OF INFECTION AT THE TIME OF THE PROCEDURE WHICH WAS PERFORMED AFTER PARACERVICAL BLOCK, AND AN IUD WAS INSERTED AFTER THE MVA PROCEDURE. THE NEXT DAY, THE WOMAN RETURNED WITH ABDOMINAL PAIN AND OTHER SIGNS OF INFECTION. OVER THE NEXT SEVERAL DAYS, SHE REQUIRED ANTIBIOTICS AND SURGERY, AND WAS RELEASED 4 DAYS LATER WITHOUT FURTHER COMPLICATIONS. THE HOSPITAL TEAM IS CONDUCTING A ROOT CAUSE ANALYSIS OF THE CASE. BELOW WAS THE SUMMARY EVENTS REPORTED BY THE USER SITE: (B)(6) 2016 (PRESUMED DATE OF MVA PROCEDURE): MVA PROCEDURE PERFORMED; IUD PROCEDURE PERFORMED - VITAL SIGNS AND BLEEDING WAS DESCRIBED AS NORMAL. ON (B)(6) 2016 (POST MVA/IUD PROCEDURE): PATIENT RETURNED TO HOSPITAL COMPLAINING OF ABDOMINAL PAIN; 10,500 WHITE BLOOD CELLS. ON (B)(6) 2016: PATIENT CONTINUED TO HAVE PAIN; DOCTORS PERFORMED A LAPAROTOMY AND DESCRIBED THE SURGICAL PART OF A PELVIC INFLAMMATORY DISEASE GRADE III AND PERFORMED THE SALPINGECTOMY. PATIENT WAS TRANSFERRED TO RECOVERY AND WAS OBSERVED TO SHOW SIGNS OF HYPOVOLEMIC SHOCK. THE DOCTORS PERFORMED ANOTHER LAPAROTOMY, AND DISCOVERED A HEMORRHAGIC FOLLICLE IN THE CONTRALATERAL OVARY. A PARTIAL RESECTION OF THE OVARY CONTROL HEMOSTASIS WAS PERFORMED. ON (B)(6) 2016: PATIENT HAD WHITE LEUKOCYTOSIS OF 20,000 BUT DID NOT RETURN TO FEVER; CIPROFLOXACIN AND METRONIDAZOLE AND THEN DOXYCYCLINE WAS ADMINISTERED. ON (B)(6)2016: PATIENT WAS DISCHARGED WITHOUT FURTHER COMPLICATIONS.