ARNDT ENDOBRONCHIAL BLOCKER SET
Report
- Report Number
- 1820334-2024-00613
- Event Type
- Injury
- Date Received
- May 3, 2024
- Report Date
- July 29, 2024
- Manufacturer
- COOK INC
- Product Code
- CBI
- PMA / PMN Number
- K021920
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Occupation
- OTHER
- Health Professional
- N
Narratives
E1 - CUSTOMER (PERSON): POSTAL CODE: (B)(6). G4 - PMA/510(K) #: K160542. THIS REPORT INCLUDES INFORMATION KNOWN AT THIS TIME. A FOLLOW UP REPORT WILL BE SUBMITTED SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE. 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.
CORRECTION: B1, B2, H1, H6- ANNEX E AND ANNEX F ADDITIONAL INFORMATION: B5 INVESTIGATION ¿ EVALUATION: IT WAS REPORTED THAT THE BLOCKER BALLOON OF AN ARNDT ENDOBRONCHIAL BLOCKER SET DEFLATED WITHIN A FEW HOURS OF PLACEMENT TO TREAT A MASSIVE HEMOPTYSIS ON AN UNKNOWN PATIENT. THE DEVICE WAS NOTED TO BE DEFLATED BY THE NEXT MORNING; THEREFORE, IT WAS REMOVED AND REPLACED. NO MANIPULATION BY THE STAFF NOR BREAKAGE OF THE BALLOON WAS OBSERVED. THE BALLOON WAS REINFLATED OUTSIDE OF THE PATIENT BUT DID NOT REMAIN INFLATED. NO OTHER ADVERSE EVENTS WERE REPORTED DUE TO THIS OCCURRENCE. REVIEWS OF QUALITY CONTROL, MANUFACTURING INSTRUCTIONS (MI), INSTRUCTIONS FOR USE (IFU), AND TRENDS WERE CONDUCTED DURING THE INVESTIGATION. THE COMPLAINT DEVICE WAS NOT RETURNED; THEREFORE, NO PHYSICAL EXAMINATIONS COULD BE PERFORMED. HOWEVER, A DOCUMENT-BASED INVESTIGATION EVALUATION WAS PERFORMED. A REVIEW OF THE DEVICE MASTER RECORD (DMR) CONCLUDED THAT SUFFICIENT INSPECTION ACTIVITIES ARE IN PLACE TO IDENTIFY THIS FAILURE MODE PRIOR TO DISTRIBUTION. A REVIEW OF THE DEVICE HISTORY RECORD (DHR) WAS UNABLE TO BE COMPLETED DUE TO A LACK OF LOT INFORMATION. AN EXPANDED SALES SEARCH TO THE CUSTOMER WAS UNABLE TO IDENTIFY THE COMPLAINT LOT. BASED ON THE AVAILABLE INFORMATION, COOK HAS CONCLUDED THAT THE DEVICE WAS MANUFACTURED TO SPECIFICATION AND THAT THERE IS NO EVIDENCE SUGGESTING NONCONFORMING PRODUCT EXISTS EITHER IN HOUSE OR IN THE FIELD. COOK ALSO REVIEWED PRODUCT LABELING. THE IFU [C_T_AEBS_REV6] ¿ARNDT ENDOBRONCHIAL BLOCKER SET,¿ PACKAGED WITH THE DEVICE CONTAINS THE FOLLOWING IN RELATION TO THE REPORTED FAILURE MODE: INTENDED USE, THE ARNDT ENDOBRONCHIAL BLOCKER SET IS INTENDED TO DIFFERENTIALLY INTUBATE A PATIENT¿S BRONCHUS IN ORDER TO ISOLATE THE LEFT OR RIGHT LUNG FOR PROCEDURES THAT REQUIRE ONE-LUNG VENTILATION. WARNINGS: ¿THE ENCLOSED BLOCKER BALLOON IS A HIGH-VOLUME, LOW-PRESSURE DESIGN. EXCESSIVE MANIPULATION OVER A PROLONGED PERIOD MAY CAUSE BALLOON RUPTURE OR DEFLATION.¿ PRECAUTIONS: ¿ CAUTION IS RECOMMENDED WHEN WORKING NEAR THE HILUM. THE BALLOON POSITION SHOULD BE VERIFIED TO PREVENT INADVERTENT BALLOON DAMAGE. CARE SHOULD BE TAKEN TO ENSURE THE BALLOON REMAINS FULLY INFLATED DURING LONGER PROCEDURES.¿ HOW SUPPLIED: ¿-STORE IN A DARK, DRY, COOL PLACE. AVOID EXTENDED EXPOSURE TO LIGHT. UPON REMOVAL FROM PACKAGE, INSPECT THE PRODUCT TO ENSURE NO DAMAGE HAS OCCURRED.¿ BASED ON THE INFORMATION PROVIDED, NO DEVICE RETURN, AND THE RESULTS OF THE INVESTIGATION, COOK CONCLUDED THE CAUSE OF THIS EVENT IS THE USER'S FAILURE TO FOLLOW INSTRUCTIONS. THE PRODUCTS IFU INSTRUCTS USERS TO ENSURE THE BALLOON REMAINS FULLY INFLATED DURING LONGER PROCEDURES. IN THIS EVENT, THE DEVICE WAS USED TO ISOLATE ONE LUNG DUE TO A PULMONARY HEMORRHAGE. THE DEVICE REMAINED IN PLACE OVERNIGHT. THE DEVICE WAS NOT BEING USED AS AN ADJUNCT DEVICE WITHIN A PRIMARY PROCEDURE THAT REQUIRED ONE-LUNG ISOLATION, WHICH IS ITS INTENDED USE. THE APPROPRIATE PERSONNEL HAVE BEEN NOTIFIED. COOK WILL CONTINUE TO MONITOR FOR SIMILAR COMPLAINTS. PER THE RISK ASSESSMENT NO FURTHER ACTION IS REQUIRED. THIS REPORT IS REQUIRED BY THE FDA UNDER 21 CFR PART 803 AND IS BASED ON UNCONFIRMED INFORMATION SUBMITTED BY OTHERS. NEITHER THE SUBMISSION OF THIS REPORT NOR ANY STATEMENT CONTAINED HEREIN IS INTENDED TO BE AN ADMISSION THAT ANY COOK DEVICE IS DEFECTIVE OR MALFUNCTIONED, THAT A DEATH OR SERIOUS INJURY OCCURRED, NOR THAT ANY COOK DEVICE CAUSED, CONTRIBUTED TO, OR IS LIKELY TO CAUSE OR CONTRIBUTE TO A DEATH OR SERIOUS INJURY IF A MALFUNCTION OCCURRED.
BLANK FIELDS ON THIS FORM INDICATE THE INFORMATION IS UNKNOWN, UNAVAILABLE, OR UNCHANGED. ADDITIONAL INFORMATION: D2B (ADDITIONAL PRODUCT CODE), D4 (RPN), D9. CORRECTION: G4. B3 - DATE OF EVENT: UNSPECIFIED, WITHIN THE LAST TWO MONTHS. D2A - COMMON DEVICE NAME: ADDITIONAL NAMES: TUBE, BRONCHIAL (W/WO CONNECTOR). D2B - ADDITIONAL PRODUCT CODE: BTS. THIS REPORT INCLUDES INFORMATION KNOWN AT THIS TIME. A FOLLOW-UP REPORT WILL BE SUBMITTED SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE. THIS REPORT IS REQUIRED BY THE FDA UNDER 21 CFR PART 803 AND IS BASED ON UNCONFIRMED INFORMATION SUBMITTED BY OTHERS. NEITHER THE SUBMISSION OF THIS REPORT NOR ANY STATEMENT CONTAINED HEREIN IS INTENDED TO BE AN ADMISSION THAT ANY COOK DEVICE IS DEFECTIVE OR MALFUNCTIONED OR THAT A DEATH OR SERIOUS INJURY OCCURRED; NOR IS IT ADMISSION THAT ANY COOK DEVICE CAUSED, CONTRIBUTED TO, OR IS LIKELY TO CAUSE OR CONTRIBUTE TO A DEATH OR SERIOUS INJURY IF A MALFUNCTION OCCURRED.
IT WAS REPORTED THAT THE BLOCKER BALLOON OF AN ARNDT ENDOBRONCHIAL BLOCKER SET DEFLATED WITHIN A FEW HOURS OF PLACEMENT TO TREAT A MASSIVE HEMOPTYSIS ON AN UNKNOWN PATIENT. THE DEVICE WAS NOTED TO BE DEFLATED BY THE NEXT MORNING. NO MANIPULATION BY THE STAFF NOR BREAKAGE OF THE BALLOON WAS OBSERVED. ADDITIONAL INFORMATION REGARDING THE EVENT AND PATIENT OUTCOME HAS BEEN REQUESTED BUT IS CURRENTLY UNAVAILABLE.
ADDITIONAL INFORMATION WAS PROVIDED. IT WAS REPORTED THAT THE BALLOON WAS SUCCESSFULLY REPLACED AFTER IT DEFLATED. AFTER THE COMPLAINT DEVICE WAS REMOVED FROM THE PATIENT, INFLATION WAS TESTED; HOWEVER THE BALLOON WOULD NOT STAY INFLATED.
ADDITIONAL INFORMATION RECEIVED 17MAY2024. THE DEVICE WAS PLACED AT AN UNSPECIFIED DATE WITHIN THE LAST TWO MONTHS. THE DEVICE WAS REINFLATED BUT DID NOT REMAIN INFLATED. NO OTHER ADVERSE EFFECTS FOR THE PATIENT HAVE BEEN REPORTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 141023 | ARNDT ENDOBRONCHIAL BLOCKER SET | CBI TUBE, TRACHEAL/BRONCHIAL | CBI | COOK INC | N/A | UNKNOWN |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Unknown | Required Intervention |