ATLANTIS SR PRO2 CORONARY IMAGING CATHETER, MODEL 39014
Report
- Report Number
- 2134265-2011-01898
- Event Type
- Injury
- Date Received
- May 26, 2011
- Date of Event
- April 27, 2011
- Report Date
- April 27, 2011
- Manufacturer
- BOSTON SCIENTIFIC - FREMONT
- Product Code
- DQO
- PMA / PMN Number
- K063312
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Occupation
- PHYSICIAN
Narratives
AGE AT TIME OF EVENT: 18 YEARS OR OLDER. (B)(4).
DEVICE EVALUATED BY MANUFACTURER: EXAMINATION OF THE RETURNED DEVICE REVEALED A KINK WAS OBSERVED IN THE BROKEN DISTAL TIP ASSEMBLY AT 0.8CM FROM DISTAL TIP END SIDE. THE DISTAL TIP ASSEMBLY WAS BROKEN OFF WHEN RECEIVED. THE UNIT WAS RECEIVED INTO TWO PIECES THE DISTAL TIP END WAS 2.3CM LONG AND THE REST IS 168.6CM LONG. THE BROKEN DISTAL TIP APPEARED BRITTLE. DURING IMAGE CHARACTERIZATION TESTING, A GOOD SQUARE IMAGE APPEARED IN THE SYSTEM AND THE PRODUCT PERFORMED WITHIN SPECIFICATION. FULL IMAGE CHARACTERIZATION TESTING CANNOT BE PERFORMED BASED ON THE RETURNED CONDITION OF THE CATHETER. NO OTHER ISSUES OR DEFECTS WERE OBSERVED DURING VISUAL OR FUNCTIONAL ANALYSIS OF THE RETURNED DEVICE. OXIDATION ANALYSIS REVEALED HIGH LEVELS OF OXIDATION AT THE SURFACE OF THE BRITTLE FRACTURE SITE. THE MANUFACTURING BATCH RECORD REVIEW CONFIRMED THAT THE DEVICE MET ALL MATERIAL, ASSEMBLY AND PERFORMANCE SPECIFICATIONS. THE MOST PROBABLE ROOT CAUSE IS DESIGN DUE TO THE OXIDATION OF THE CATHETER WHICH CAUSES EMBRITTLEMENT AND INCREASES THE LIKELIHOOD OF TIP DETACHMENTS OF THIS NATURE. (B)(4).
IT WAS REPORTED THAT DURING A DIAGNOSTIC PROCEDURE, A TIP DETACHMENT OCCURRED. THE 90% STENOSED LESION WAS LOCATED IN THE MODERATELY TORTUOUS AND MODERATELY CALCIFIED RENAL ARTERY. AN ATLANTIS SR PRO² IMAGING CATHETER WAS ADVANCED HOWEVER DIFFICULTY CROSSING THE LESION WAS ENCOUNTERED DUE TO THE SEVERE VESSEL CALCIFICATION. THE ATLANTIS SR PRO² IMAGING CATHETER WAS REMOVED IN ORDER TO PREDILATE THE LESION. HOWEVER UPON REMOVAL THE TIP OF THE ATLANTIS SR PRO² BECAME CAUGHT ON THE CALCIFIED LESION, AND THE RO MARKER REMAINED INSIDE THE RENAL ARTERY AND ABOUT 25CM OF THE DISTAL TIP DETACHED. THE ATLANTIS SR PRO² IMAGING CATHETER WAS REMOVED AND THE DETACHED TIP AND THE RO MARKER WERE REMOVED WITH A SNARE. THE PROCEDURE WAS COMPLETED WITH PREDILATION OF THE LESION WITH AN UNSPECIFIED BALLOON AND PLACEMENT OF AN EXPRESS LD STENT AT THE TARGET LESION. NO PATIENT COMPLICATIONS WERE REPORTED AND THE PATIENT'S STATUS IS STABLE.
IT WAS REPORTED THAT DURING A DIAGNOSTIC PROCEDURE, A TIP DETACHMENT OCCURRED. THE 90% STENOSED LESION WAS LOCATED IN THE MODERATELY TORTUOUS AND MODERATELY CALCIFIED RENAL ARTERY. AN ATLANTIS SR PRO² IMAGING CATHETER WAS ADVANCED HOWEVER DIFFICULTY CROSSING THE LESION WAS ENCOUNTERED DUE TO THE SEVERE VESSEL CALCIFICATION. THE ATLANTIS SR PRO² IMAGING CATHETER WAS REMOVED IN ORDER TO PREDILATE THE LESION. HOWEVER UPON REMOVAL THE TIP OF THE ATLANTIS SR PRO² BECAME CAUGHT ON THE CALCIFIED LESION, AND THE RO MARKER REMAINED INSIDE THE RENAL ARTERY AND ABOUT 25CM OF THE DISTAL TIP DETACHED. THE ATLANTIS SR PRO² IMAGING CATHETER WAS REMOVED AND THE DETACHED TIP AND THE RO MARKER WERE REMOVED WITH A SNARE. THE PROCEDURE WAS COMPLETED WITH PREDILATION OF THE LESION WITH AN UNSPECIFIED BALLOON AND PLACEMENT OF AN EXPRESS LD STENT AT THE TARGET LESION. NO PATIENT COMPLICATIONS WERE REPORTED AND THE PATIENT'S STATUS IS STABLE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | ATLANTIS SR PRO2 CORONARY IMAGING CATHETER, MODEL 39014 | CATHETER, INTRAVASCULAR, DIAGNOSTIC | DQO | BOSTON SCIENTIFIC - FREMONT | H749390140 | 13570480 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Required Intervention |