FDA.reportPublic FDA data

MAUDE MDR 4336163

MDR report key
4336163
Report number
3008805841-2014-00001
Event key
0
Event type
3
Date of event
2014-10-30
Date received
2014-11-21
Adverse event
3
Product problem
3
Patients in event
0
Reporter occupation
0
Health professional
3
Initial report to FDA
3
Event location
0

Manufacturer Contact#

Contact
MR. SCOTT BLOOD
Address
1 KENDALL SQ SUITE B7501 CAMBRIDGE MA 02139 US
Phone
617-617-6172
Report source
M
Manufacturer link flag
Y

Devices#

Seq, Brand, Generic table
SeqBrandGenericManufacturerProduct codeModelCatalogLotPMA510(k)ImplantEvaluatedAvailability
1NVISIONVLE OPTICAL PROBENVISIONVLE OPTICAL PROBENINEPOINT MEDICAL INC.NQQ95101-1495101-14004337Y Y

Patients#

Sequence, Received, Treatment table
SequenceReceivedTreatmentOutcome
12014-11-2101. H; 2. R

Event Narratives#

D

Patient 1

(B)(6) YEAR OLD FEMALE WITH HISTORY OF ACHALASIA WITH 2-3 PRIOR TREATMENTS OF BOTOX MD DID THE PRELIMINARY ENDOSCOPY AND PROVIDED THE MEASUREMENT FOR THE TOP OF THE GASTRIC FOLDS @40CM. MD CHOSE TO USE NVISIONVLE 14MM OPTICAL PROBE, STATED THAT THE EGJ FELT TIGHT BUT COULD ADVANCE THE ENDOSCOPE THRU THE EG JUNCTION AND INTO THE STOMACH WITHOUT DIFFICULTY. SHE PASSED THE OPTICAL PROBE DOWN THE BIOPSY CHANNEL OF THE SCOPE INTO AN INSUFFLATED STOMACH PER IFU. SCOPE AND PROBE PULLED BACK TO EGJ (40 EM) THEN BOTH PULLED BACK AN ADDITIONAL SCM TO 34CM. MD ASKED TECH TO INFLATE BALLOON TO 10 PSI PER IFU. FIRST SCOUT SCAN PERFORMED: NO GASTRIC CARDIA VISUALIZED ON THE SCAN. MD ASKED TECH TO COMPLETELY DEFLATE BALLOON PER IFU. PHYSICIAN ADVANCED SCOPE AND PROBE 1 EM TO 35CM AND THEN INFLATED THE BALLOON TO 10PSI. SECOND SCOUT SCAN WAS PERFORMED. GOOD CENTERING AND POSITIONING OBTAINED. MD REQUESTED FULL SCAN AT 10PSI. MD HAPPY WITH SCAN AND IMAGING PRODUCED. MD ASKED TECH TO COMPLETELY DEFLATE BALLOON AND OPTICAL PROBE REMOVED FROM BIOPSY CHANNEL OF SCOPE. NO BLOOD NOTED WHEN OPTICAL PROBE REMOVED. SCOPE REMOVED. PHYSICIAN DECIDED TO PERFORM PERORAL ENDOSCOPIC MYOTOMY (POEM) UTILIZING ANTERIOR APPROACH. OVER TUBE (NO MFR IDENTIFIED) INSERTED INTO THE ESOPHAGUS. SCOPE REINTRODUCED THRU OVER TUBE ALONG WITH ENDOFIIP EF-325N (CROSPON, CARLSBAD, CA) CATHETER ALONG THE SIDE OF SCOPE. SCOPE WAS THEN REMOVED, THE ENDOFLIP WAS LEFT TO PERFORM A SERIES OF PRESSURE MEASUREMENTS, THEN REMOVED. SCOPE REINTRODUCED THRU OVER TUBE. PHYSICIAN BEGAN INITIATING TUNNEL BETWEEN MUCOSA AND MUSCULARIS FOR MYOTOMY. AFTER TUNNELING STARTED, STAFF NOTICED DISTENTION OF THE ABDOMEN. PHYSICIAN CAME OUT OF TUNNEL TO ADVANCE THE SCOPE INTO THE STOMACH TO AIDE IN VENTILATION AND NOTICED A TEAR IN THE MUCOSA NEAR THE EGJ. AFTER STOMACH FELT SOFTER, MD RETURNED TO ESOPHAGUS TO FURTHER EVALUATE THE TEAR. PHYSICIAN DECIDED TO CLOSE TEAR WITH SEVERAL BSC AND OVESCO CLIPS, BUT TISSUE WAS NOT VIABLE ENOUGH TO HOLD CLIPS FOR EXTENDED PERIOD OF TIME, PATIENT WAS TRANSFERRED ONTO FLUOROSCOPY TABLE AND HAD A FULLY COVERED ESOPHAGEAL METAL STENT INSERTED OVER TEAR FOR CLOSURE. STENT WAS SUTURED INTO PLACE AND MYOTOMY TUNNEL WAS CLOSED WITH BSC AND OVESCO CLIPS.

N

Patient 1

RETURN OPTICAL PROBE EVALUATED. DEVICE HISTORY RECORD FOR LOT #004337 DID NOT PRODUCE ANY ANOMALIES OR OUT-OF-SPECIFICATION CONDITIONS. EVALUATION OF INTACT RETURNED OPTICAL PROBE DID NOT SHOW ANY EVIDENCE OF CAUSING TISSUE DAMAGE; I.E. NO BLOOD OR TISSUE DEBRIS WAS OBSERVED ON THE BALLOON OR PROBE TIP, NO SHARP OR JAGGED EDGES WHICH COULD PRECIPITATE A TEAR. IT WAS SUSPECTED BY THE PHYSICIAN IN A LATER DISCUSSION OF THE INCIDENT THAT THE TEAR WAS MOST LIKELY A SUPERFICIAL DEFECT IN THE WALL OF THE MUCOSA, AND THE POEM TUNNELING EXACERBATED THE SUPERFICIAL DEFECT INTO A FULL THICKNESS DEFECT. PICTURES FROM THE ENDOSCOPY FEED PROVED INCONCLUSIVE. THE VIDEO FROM THE WHITE-LIGHT ENDOSCOPY WAS NOT AVAILABLE, SO THE MOMENT IN WHICH THE TEAR OCCURRED, OR PREVIOUS TEAR WAS AGGRAVATED, COULD NOT BE SHOWN. SINCE THE OPTICAL PROBE DID NOT APPEAR TO HAVE DEBRIS FROM A TEAR OR DAMAGE THAT WOULD LIKELY CAUSE AN INITIAL TEAR, IT IS INCONCLUSIVE THAT THE OPTICAL PROBE CAUSED THE TEAR THAT LED TO THE INTERVENTION AND PROLONGED HOSPITALIZATION. IT IS EQUALLY AS LIKELY THAT THE OTHER MEDICAL DEVICES USED IN THE PROCEDURE CAUSED THE INITIAL TEAR; I.E. THE OVER TUBE, ENDOFLIP, THE ENDOSCOPE AS IT TUNNELED, AND THE MYOTOMY BLADE. THE RESULTS OF THE INITIAL INVESTIGATION ARE INCONCLUSIVE.