FDA.reportPublic FDA data

MAUDE MDR 8386950

MDR report key
8386950
Report number
3006897778-2019-00002
Event key
0
Event type
3
Date of event
2019-01-29
Date received
2019-03-04
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
AMY BEEMAN
Address
161 CHESHIRE LANE, SUITE 100 PLYMOUTH MN 55441 US
Phone
763-763-7632
Report source
M
Manufacturer link flag
Y

Devices#

Seq, Brand, Generic table
SeqBrandGenericManufacturerProduct codeModelCatalogLotPMA510(k)ImplantEvaluatedAvailability
1ENDOFLIPSYSTEM, GASTROINTESTINAL MOTILITY (ELECTRICAL)CROSPON LTDFFXEF-325NEF-325N* N

Patients#

Sequence, Received, Treatment table
SequenceReceivedTreatmentOutcome
12019-03-0401. R

Event Narratives#

N

Patient 1

IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

D

Patient 1

ACCORDING TO THE REPORTER, THE CATHETER WAS PLACED WITHOUT A SCOPE AND THE TIP OF THE CATHETER WENT IN TO THE CUT IN THE ESOPHAGUS WHEN THEY DID THE POEM PROCEDURE (PERORAL ENDOSCOPIC MYOTOMY). THE PHYSICIAN PERFORMED AN ENDOFLIP PROCEDURE, THEN PERFORMED A POEM PROCEDURE. IT WAS NOTED THAT THIS WAS THE FIRST POEM PROCEDURE PERFORMED BY THE PHYSICIAN. THEN, THE PHYSICIAN PASSED THE SCOPE TO EXAMINE THE ESOPHAGUS, AND CLOSED THE MUCOSOTOMY WITH CLIPS AT 32CM. THE SCOPE WAS REMOVED AND PLACED THE CATHETER AGAIN, BLIND. THE PHYSICIAN EXPERIENCED SOME TIGHTNESS AND DID NOT SEE THE GASTROESOPHAGEAL JUNCTION ON THE MONITOR. THE FLIP WAS REPOSITIONED AND EXPERIENCED SOME RESISTANCE, SO THE PHYSICIAN REMOVED THE CATHETER AND REPLACED THE SCOPE. THAT?S WHEN THE PHYSICIAN FOUND A MUCOSAL TEAR AT 42CM, AND DUE TO THE MYOTOMY PERFORMED, THE TEAR WAS FULL THICKNESS INTO THE PERITONEAL CAVITY. THE MUCOSAL TEAR WAS CLOSED WITH CLIPS. THE PATIENT WAS THEN KEPT NPO (NOTHING BY MOUTH) AND HAD AN ANTIBIOTIC FOR A FEW DAYS, AND SLOWLY ADVANCED TO CLEAR LIQUID DIET. THE PATIENT UNDERWENT A BARIUM SWALLOW ON POST-PROCEDURE DAY 3 WHICH DID NOT SHOW A LEAK BUT DID SHOW SLOW EMPTYING INTO THE STOMACH. ON POST-PROCEDURE DAY 4, THE PATIENT HAD SYMPTOMATIC BRADYCARDIA AND HAD TO GET A PACEMAKER. THE PATIENT UNDERWENT A CT SCAN TO SEE IF THERE WERE ANY HEMATOMAS OR COLLECTIONS AROUND THE ESOPHAGUS THAT COULD HAVE BEEN IMPINGING ON THE HEART, BUT THE CT SCAN WAS NORMAL. THE PATIENT WENT HOME IN STABLE CONDITION ON POST-PROCEDURE DAY 8. THE PHYSICIAN FELT LIKE THE SOFT TIP OF THE CATHET ER WAS TOO FLEXIBLE, THAT IT ACTUALLY BENT AND ALLOWED THE MORE RIGID CATHETER TO LEAD, WHICH WAS A RISK FOR PERFORATION. THE PHYSICIAN WAS TRAINED TO PLACE THE CATHETER BLIND, WHICH WAS THE RECOMMENDATION AND WAS ADVISED TO FOLLOW THE CATHETER WITH THE SCOPE IN UNIQUE CASES, LIKE POEM PROCEDURES, WHERE MUCOSOTOMIES AND MYOTOMIES HAVE BEEN PERFORMED AND WEAKENS THE STRUCTURE OF THE ESOPHAGUS. THE PHYSICIAN STATED THAT WILL NOW FOLLOW THE CATHETER WITH THE SCOPE AND PLACE IT UNDER DIRECT VISION FOR ALL FUTURE POEMS.