ARNDT ENDOBRONCHIAL BLOCKER SET
Report
- Report Number
- 1820334-2021-01510
- Event Type
- Malfunction
- Date Received
- June 15, 2021
- Date of Event
- June 3, 2021
- Report Date
- May 19, 2022
- Manufacturer
- COOK INC
- Product Code
- CBI
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CA, US
- Reporter Occupation
- NURSE
- Health Professional
- Yes
Narratives
CORRECTION: H6 - ANNEX E. 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.
BLANK FIELDS ON THIS FORM INDICATE THE INFORMATION IS UNCHANGED, UNKNOWN OR UNAVAILABLE. INVESTIGATION ¿ EVALUATION. RONALD REAGAN UCLA MEDICAL CENTER INFORMED COOK THAT ON 03JUN2021 THE BALLOON IN A C-AEBS-9.0-78-SPH-AS (ARNDT ENDOBRONCHIAL BLOCKER SET) WOULD NOT INFLATE OR DEFLATE. THE BALLOON DISLODGED WHILE UNDER BRONCHOSCOPY AND THE DEVICE WAS REMOVED. UPON REMOVAL IT WAS NOTICED THAT THE DEVICE WAS AT AN ODD ANGLE WHEN THE BALLOON WAS INFLATED, AND THE BALLOON INFLATED ASYMMETRICALLY. A NEW ENDOBRONCHIAL BLOCKER WAS OPENED TO COMPLETE THE PROCEDURE SUCCESSFULLY. THE PATIENT EXPERIENCED DESATURATION BECAUSE OF THE FAILURE BUT THIS DID NOT LEAD TO PROLONGED HOSPITALIZATION. A REVIEW OF THE COMPLAINT HISTORY, DEVICE HISTORY RECORD, INSTRUCTIONS FOR USE (IFU), MANUFACTURING INSTRUCTIONS, AND QUALITY CONTROL PROCEDURES, AS WELL AS A VISUAL INSPECTION AND A FUNCTIONAL TEST OF THE RETURNED DEVICE, WERE CONDUCTED DURING THE INVESTIGATION. COOK RECEIVED ONE USED DEVICE. DURING TABLETOP TESTING, A SYRINGE WAS USED TO TEST THE BALLOON. USING THE SYRINGE, INFLATION AND DEFLATION OF THE BALLOON WAS POSSIBLE. IT WAS NOTED THAT ASYMMETRIC INFLATION WAS PRESENT IN THE BALLOON. ADDITIONALLY, A DOCUMENT BASED INVESTIGATION EVALUATION WAS PERFORMED. COOK CONCLUDED THAT SUFFICIENT INSPECTION ACTIVITIES ARE IN PLACE TO IDENTIFY THIS FAILURE MODE PRIOR TO DISTRIBUTION. IN RESPONSE TO THIS INCIDENT, COOK REVIEWED THE DEVICE HISTORY RECORD (DHR). THE DHR FOR LOT 10062469 RECORDS NO RELEVANT NON-CONFORMANCES. A DATABASE SEARCH FOR COMPLAINTS ON THE REPORTED LOT FOUND NO ADDITIONAL COMPLAINTS REPORTED FROM THE FIELD. COOK CONCLUDED THAT NO NONCONFORMING PRODUCT FROM THIS LOT EXISTS IN HOUSE OR IN THE FIELD. BASED ON THE DEVICE MASTER RECORD, DEVICE HISTORY RECORD, AND DEVICE FAILURE ANALYSIS, THERE IS NO INDICATION THE DEVICE WAS MANUFACTURED OUT OF SPECIFICATION. COOK ALSO REVIEWED PRODUCT LABELING. THE IFU PACKAGED WITH THE DEVICE CONTAINS THE FOLLOWING IN RELATION TO THE REPORTED FAILURE MODE: 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.¿ THE INFLATION/DEFLATION DIFFICULTIES COULD NOT BE REPLICATED WITH THE RETURNED DEVICE, BUT ASYMMETRIC INFLATION WAS NOTED. IT IS POSSIBLE THAT ASYMMETRIC INFLATION OCCURRED DURING THE PROCEDURE DUE TO THE MULTIPLE INFLATIONS, BUT THIS CANNOT BE CONFIRMED. BASED ON THE INFORMATION PROVIDED, INSPECTION OF THE RETURNED DEVICE, AND THE RESULTS OF THE INVESTIGATION, IT WAS DETERMINED THE CAUSE OF THIS EVENT IS COMPONENT FAILURE UNRELATED TO MANUFACTURING OR DESIGN DEFICIENCIES. 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.
THE ARNDT ENDOBRONCHIAL BLOCKER SET WAS BEING USED IN AN ATTEMPT TO BLOCK THE RIGHT LUNG IN ORDER TO INTUBATE THE PATIENT VIA THE LEFT MAINSTEM. THE PATIENT EXPERIENCED DESATURATION AS A RESULT OF THE FAILURE AND IT WAS CONFIRMED THAT A NEW ENDOBRONCHIAL BLOCKER SET WAS USED TO SUCCESSFULLY INTUBATE THE PATIENT. IT WAS REPORTED THAT AS THE PATIENT WAS ALREADY HOSPITALIZED, THE EVENT DID NOT LEAD TO INITIAL OR PROLONGED HOSPITALIZATION.
NO ADDITIONAL INFORMATION REGARDING THE PATIENT AND/OR EVENT HAS BEEN RECEIVED SINCE THE PREVIOUS MEDWATCH REPORT WAS SENT.
THIS REPORT INCLUDES INFORMATION KNOWN AT THIS TIME. A FOLLOW UP REPORT WILL BE SUBMITTED SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE.
IT WAS REPORTED THAT DURING THE INSERTION OF AN UNKNOWN ENDOBRONCHIAL BLOCKER IN AN UNKNOWN PROCEDURE, PHYSICIANS WERE NO LONGER ABLE TO INFLATE OR DEFLATE THE BALLOON. THE DEVICE APPEARED TO BE FUNCTIONING NORMALLY, BUT WAS NOTED TO BE AT AN ODD ANGLE WHEN INFLATED. AFTER AN UNKNOWN PERIOD OF TIME, THE BALLOON WAS UNABLE TO BE INFLATED OR DEFLATED IN ORDER TO SECURE THE TUBE. AT ONE POINT, THE BALLOON DISLODGED WHILE UNDER BRONCHOSCOPY AND REQUIRED TROUBLESHOOTING. FOLLOWING REMOVAL OF THE DEVICE, THE BALLOON APPEARED TO BE INFLATING UNEVENLY. A SECOND ENDOBRONCHIAL BLOCKER OF THE SAME SIZE WAS OPENED AND SUCCESSFULLY PLACED IN THE PATIENT. ADDITIONAL INFORMATION REGARDING EVENT AND DEVICE DETAILS HAVE BEEN REQUESTED, BUT IS CURRENTLY UNAVAILABLE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 902193 | ARNDT ENDOBRONCHIAL BLOCKER SET | CBI TUBE, TRACHEAL/BRONCHIAL | CBI | COOK INC | N/A | 10062469 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 76 YR | Male |