ZIPWIRE HYDROPHILIC GUIDE WIRE
Report
- Report Number
- 2134265-2011-03250
- Event Type
- Injury
- Date Received
- August 15, 2011
- Report Date
- August 25, 2011
- Manufacturer
- BOSTON SCIENTIFIC - MAPLE GROVE
- Product Code
- DQX
- PMA / PMN Number
- K000011
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- WV, US
- Reporter Occupation
- HEALTH PROFESSIONAL
Narratives
DEVICE (B)(4) RELATES TO COMPONENT (B)(4). (B)(4).
DEVICE EVALUATED BY MANUFACTURER: EXTERNAL MANUFACTURER PRODUCT ANALYSIS: THE RETURNED DEVICE WAS RETURNED PARTIALLY RELOADED INTO THE DISPENSER ASSEMBLY. NO OTHER ORIGINAL PACKAGING OR OTHER DEVICES INVOLVED IN THE REPORTED EVENT WAS INCLUDED. THE SPECIMEN PRESENTED AN OVERALL LENGTH OF 150.15CM AND A FINISHED DIAMETER OF .03390¿ TO .03455¿. A GAGE BUSHING CERTIFIED TO BE .0350¿ PASSED OVER THE LENGTH OF THE SPECIMEN WITH NO MORE EFFORT THAN THE MASS OF THE BUSHING SLIDING DOWN THE WIRE SHAFT UNAIDED, EXCEPT BY GRAVITY. NOTE ALL DIAMETER MEASUREMENTS WERE ACQUIRED WITH A NON-CONTACT, LASER MICROMETER AT 23OC AND AMBIENT HUMIDITY AFTER ALLOWING THE SPECIMEN DEVICE TO BECOME DRY AFTER HYDRATING THE SPECIMEN DEVICE WITH BLOOD-BANK SALINE FOR REMOVAL FROM THE DISPENSER ASSEMBLY. THE SPECIMEN PRESENTED NO INDICATIONS OF MANUFACTURING DEFECT OR ANOMALY. AFTER INJECTING THE DISPENSER ASSEMBLY WITH APPROXIMATELY 10CC OF ROOM TEMPERATURE (22O) BLOOD-BANK SALINE, THE SPECIMEN WAS EASILY REMOVED FROM THE DISPENSER. THE SPECIMEN PRESENTED A 7.00CM SEGMENT OF POLYMER JACKET MATERIAL SKIVED FROM THE SPECIMEN, EXPOSING 6.50CM OF CORE WIRE IN A PROXIMAL TO DISTAL ORIENTATION, TERMINATING 1.30CM FROM THE DISTAL TIP. THE SPECIMEN COATING OTHERWISE APPEARED VISUALLY AND TACTILELY CONSISTENT WHEN EXAMINED AT 1X 18 INCHES, UNAIDED, WET. AFTER ALLOWING IT TO DRY OUT, WHEN EXAMINED AT 1X 18 INCHES, UNAIDED, THE VISUAL AND TACTILE SURFACE APPEARANCE OF THE SPECIMEN WAS ACCEPTABLE PER THE INSPECTION CRITERIA. MICROSCOPICALLY THE SPECIMEN COATING APPEARS TO BE SMOOTH AND CONSISTENT. EXCEPT WHERE NOTED, THE SPECIMEN DEVICE APPEARS VISUALLY AND DIMENSIONALLY CORRECT. THE MANUFACTURING BATCH RECORD REVIEW CONFIRMED THAT THE DEVICE MET ALL MATERIAL, ASSEMBLY AND PERFORMANCE SPECIFICATIONS. THE ROOT CAUSE IS DETERMINED TO BE USER RELATED BECAUSE THE COMPLAINT DEVICE SHOWED EVIDENCE OF MANIPULATION THROUGH A METAL ENTRY NEEDLE, WHICH MAY HAVE CONTRIBUTED TO THE REPORTED DISTAL TIP SEPARATION. (B)(4).
IT WAS REPORTED THAT DURING A CORONARY TREATMENT PROCEDURE, A GUIDEWIRE TIP DETACHMENT OCCURRED. THE 035X150 ANGLED GUIDEWIRE WAS USED IN PREPARATION OF A PROCEDURE AND IT WAS REPORTED THAT THE TIP SHEARED OFF OUTSIDE THE PATIENT, DURING THE CASE. THE TIP WAS RETRIEVED SUCCESSFULLY WITH NO HARM TO THE PATIENT. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME GUIDEWIRES. NO PATIENT COMPLICATIONS WERE REPORTED AND THE PATIENT'S STATUS IS OK. ADDITIONAL INFORMATION HAS BEEN REQUESTED AND IS NOT AVAILABLE.
IT WAS REPORTED THAT DURING A CORONARY TREATMENT PROCEDURE, A GUIDEWIRE TIP DETACHMENT OCCURRED. THE 035X150 ANGLED GUIDEWIRE WAS USED IN PREPARATION OF A PROCEDURE AND IT WAS REPORTED THAT THE TIP SHEARED OFF OUTSIDE THE PATIENT, DURING THE CASE. THE TIP WAS RETRIEVED SUCCESSFULLY WITH NO HARM TO THE PATIENT. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME GUIDEWIRES. NO PATIENT COMPLICATIONS WERE REPORTED AND THE PATIENT'S STATUS IS OK. ADDITIONAL INFORMATION HAS BEEN REQUESTED AND IS NOT AVAILABLE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | ZIPWIRE HYDROPHILIC GUIDE WIRE | WIRE, GUIDE, CATHETER | DQX | BOSTON SCIENTIFIC - MAPLE GROVE | M00146151B0 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Required Intervention |