UNKNOWN
Report
- Report Number
- 3002808486-2019-01890
- Event Type
- Injury
- Date Received
- December 4, 2019
- Report Date
- May 25, 2020
- Manufacturer
- WILLIAM COOK EUROPE
- Product Code
- DQX
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- UK
- Reporter Occupation
- PHYSICIAN
Narratives
MANUFACTURER REF# PR285335 SUMMARY OF INVESTIGATIONAL FINDINGS: THE INVESTIGATION IS BASED ON A REVIEW OF THE ARTICLE. IT WAS REPORTED THAT FRESH BLOOD APPEARED IN THE ENDOTRACHEAL TUBE TOWARDS THE END OF THE PROCEDURE DUE TO THE PERFORATION OF A DISTAL BRANCH BY THE GUIDEWIRE. THE HOLE WAS SEALED WITH A PLUG AND NO SEQUELAE WAS REPORTED. NO PRODUCT WAS RETURNED AND NO DETAILED INFORMATION WAS PROVIDED IN THE ARTICLE. THERE IS NO INFORMATION ON COMPLICATIONS OR DETAILS RE MANEUVERING THE LUNDERQUIST WIRE GUIDE, BUT THE FRESH BLOOD IN THE ENDOTRACHEAL TUBE IS CONCLUDED TO BE DUE TO A PERFORATION OF A DISTAL BRANCH. THE WIRE GUIDE WAS USED AS DELIVERY SYSTEM FOR A VALVE VIA FEMORAL VEIN TO THE LEFT PULMONARY ARTERY ORIGIN, BUT THE ARTICLE DOES NOT REPORT ANY SEQUELAE OR FIBROUS TISSUE FOLLOWING THE PREVIOUS OPERATIONS IN THE SAME ANATOMICAL AREA, WHICH MAY HAVE MADE THE TISSUE MORE FRIABLE/VULNERABLE TO PERFORATION DUE TO LOSS OF ELASTICITY/DECREASED TOLERANCE TOWARDS PRESSURE. CONSEQUENTLY, THE EXACT REASON FOR THE PERFORATION FROM THE PULMONARY ARTERY TO THE TRACHEA CANNOT BE DETERMINED, NOR CAN IT BE EXCLUDED THAT THE LUNDERQUIST WIRE MAY HAVE CAUSED IT. COOK WAS UNABLE TO CONDUCT A REVIEW OF THE DEVICE HISTORY RECORD, AS THE LOT NUMBER OF THE COMPLAINT DEVICE WAS NOT PROVIDED FOR THE INVESTIGATION. COOK MEDICAL WILL CONTINUE TO MONITOR FOR SIMILAR EVENTS. 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.
MANUFACTURER REF# (B)(4). ARTICLE: NOVEL USE OF A 3D PRINTED HEART MODEL TO GUIDE SIMULTANEOUS PERCUTANEOUS REPAIR OF SEVERE PULMONARY REGURGITATION AND RIGHT VENTRICULAR OUTFLOW TRACT ANEURYSM. JIVANJI S.G.M., QURESHI S.A., ROSENTHAL E. CATALOG# IS UNKNOWN BUT REFERRED TO AS COOK LUNDERQUIST WIRE. PMA/510(K) K171513. (B)(4). INVESTIGATION IS STILL IN PROGRESS.
DESCRIPTION OF EVEN ACCORDING TO ARTICEL: FRESH BLOOD APPEARED IN THE ENDOTRACHEAL TUBE TOWARDS THE END OF THE PROCEDURE DUE TO THE PERFORATION OF A DISTAL BRANCH BY THE GUIDEWIRE (NOT STATED IF IT WAS THE COOK LUNDERQUIST WIRE OR THE AMPLATZ WIRE (FROM ANOTHER MANUFACTURER) WHICH CAUSED THIS PERFORATION).THE PERFORATED BRANCH WAS SEALED WITH A 6- AND A 9-MM AMPLATZER VASCULAR PLUG II (FROM ANOTHER MANUFACTURER). THERE WAS NO FURTHER HAEMOPTYSIS, AND THE PATIENT WAS DISCHARGED 3 DAYS LATER ON DUAL ANTI-PLATELET THERAPY. PATIENT OUTCOME: THE PATIENT DID REQUIRE ADDITIONAL PROCEDURES DUE TO THIS OCCURRENCE. PERFORATION WAS SEALED WITH A 6- AND A 9-MM AMPLATZER VASCULAR PLUG II (AFROM ANOTHER MANUFACTURER). ACCORDING TO THE INITIAL REPORTER, THE PATIENT DID EXPERIENCE ADVERSE EFFECTS DUE TO THIS OCCURRENCE. BLEEDING DUE TO PERFORATION OF A DISTAL BRANCH VESSEL.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1204699 | UNKNOWN | DQX WIRE, GUIDE, CATHETER | DQX | WILLIAM COOK EUROPE | UNKNOWN |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 19 YR | Required Intervention |