ARNDT ENDOBRONCHIAL BLOCKER SET
Report
- Report Number
- 1820334-2022-01875
- Event Type
- Malfunction
- Date Received
- December 21, 2022
- Date of Event
- December 15, 2022
- Report Date
- May 19, 2023
- Manufacturer
- COOK INC
- Product Code
- CBI
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Occupation
- OTHER
- Health Professional
- N
Narratives
CUSTOMER (PERSON):(B)(6). INITIAL REPORTER OCCUPATION: ANESTHESIOLOGY/PF. 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 A REPRESENTATIVE OF BORAMAE MEDICAL CENTER (REPUBLIC OF KOREA) INFORMED COOK THAT ON (B)(6) 2022 THE BALLOON IN AN ARNDT ENDOBRONCHIAL BLOCKER SET (RPN: C-AEBS-9.0-78-SPH-AS; LOT: NS14685880) WOULD NOT INFLATE. THE PHYSICIAN COULD NOT INFLATE THE BALLOON BEFORE IT WAS USED ON THE PATIENT. THE PROCEDURE WAS COMPLETED WITH ANOTHER DEVICE. IT WAS REPORTED THAT THERE WERE NO ADVERSE EFFECTS TO THE PATIENT DUE TO THIS OCCURRENCE. REVIEWS OF THE COMPLAINT HISTORY, DEVICE HISTORY RECORD (DHR), INSTRUCTIONS FOR USE (IFU), MANUFACTURING INSTRUCTIONS, AND QUALITY CONTROL PROCEDURES, AS WELL AS A VISUAL INSPECTION AND FUNCTIONAL TEST OF THE RETURNED DEVICE, WERE CONDUCTED DURING THE INVESTIGATION. COOK RECEIVED ONE PRIOR TO USE C-AEBS-9.0-78-SPH-AS CATHETER WITH BALLOON. THE BALLOON INFLATED WITHOUT ISSUES, AND THERE WAS NO LEAKAGE. THE FAILURE COULD NOT BE REPLICATED. ADDITIONALLY, A DOCUMENT-BASED INVESTIGATION EVALUATION WAS PERFORMED. COOK COMPLETED A REVIEW OF THE PRODUCT DEVICE MASTER RECORD (DMR) AND CONCLUDED THAT SUFFICIENT INSPECTION ACTIVITIES ARE IN PLACE TO IDENTIFY THIS FAILURE MODE PRIOR TO DISTRIBUTION. COOK ALSO REVIEWED THE DEVICE HISTORY RECORD FOR LOT NS14685880 AND RECORDS ONE RELEVANT NON-CONFORMANCE FOR BALLOON DAMAGE. THERE ARE INSPECTIONS IN PLACE TO IDENTIFY THIS FAILURE BEFORE SHIPMENT, AND ALL NON-CONFORMING PRODUCT WAS SCRAPPED. A DATABASE SEARCH FOR COMPLAINTS ON THE REPORTED LOT FOUND NO ADDITIONAL COMPLAINTS REPORTED FROM THE FIELD. COOK REVIEWED PRODUCT LABELING. THE PRODUCT IFU, [C_T_AEBS_REV6] ¿ARNDT ENDOBRONCHIAL BLOCKER SET,¿ PROVIDES THE FOLLOWING INFORMATION TO THE USER RELATED TO THE REPORTED FAILURE MODE: PRECAUTIONS "FOLLOWING INSERTION OF THE BLOCKER BALLOON THROUGH THE MULTIPORT ADAPTER, THE BALLOON SHOULD BE TEST INFLATED." INSTRUCTIONS FOR USE ¿WARNING: THE LUNGS SHOULD BE CAREFULLY AUSCULTATED FOLLOWING INITIAL ENDOBRONCHIAL BLOCKER PLACEMENT AND BALLOON INFLATION TO ENSURE PROPER FUNCTIONING OF THE ENDOBRONCHIAL BLOCKER.¿ HOW SUPPLIED "UPON REMOVAL FROM PACKAGE, INSPECT HE PRODUCT TO ENSURE NO DAMAGE HAS OCCURRED." THE INFORMATION PROVIDED UPON REVIEW OF THE DMR, DHR, IFU, AND DEVICE FAILURE ANALYSIS DOES NOT INDICATE THE DEVICE WAS MANUFACTURED OUT OF SPECIFICATION. THERE IS NO EVIDENCE OF NONCONFORMING MATERIAL IN HOUSE OR IN THE FIELD. BASED ON THE INFORMATION PROVIDED, INSPECTION OF THE RETURNED DEVICE, AND THE RESULTS OF THE INVESTIGATION, COOK CONCLUDES COMPONENT FAILURE UNRELATED TO MANUFACTURING OR DESIGN DEFICIENCIES CONTRIBUTED TO THE EVENT. THE CUSTOMER STATED THE BALLOON WOULD NOT INFLATE, BUT THE DEVICE FAILURE ANALYSIS COULD NOT REPLICATE THE FAILURE. IT IS POSSIBLE THAT THE INFLATION ISSUES WERE SOLVED AFTER THE FIRST ATTEMPT AT INFLATION. 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.
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.
IT WAS REPORTED THAT THE BALLOON OF AN ARNDT ENDOBRONCHIAL BLOCKER SET WAS UNABLE TO BE INFLATED AS IT WAS BEING TESTED BY THE PHYSICIAN PRIOR TO USE ON AN UNKNOWN PATIENT FOR AN UNKNOWN PROCEDURE. THE PATIENT DID NOT EXPERIENCE ANY ADVERSE EFFECTS OR REQUIRE ANY ADDITIONAL PROCEDURES DUE TO THIS OCCURRENCE. ADDITIONAL INFORMATION REGARDING EVENT DETAILS HAS BEEN REQUESTED BUT IS CURRENTLY UNAVAILABLE.
NO ADDITIONAL INFORMATION REGARDING THE PATIENT AND/OR EVENT HAS BEEN RECEIVED SINCE THE PREVIOUS MEDWATCH REPORT WAS SENT.
IN ADDITIONAL INFORMATION RECEIVED ON 28DEC2022, IT WAS REPORTED THAT ANOTHER DEVICE WAS USED TO COMPLETE THE PROCEDURE, AS THE OR WAS EQUIPPED WITH IDENTICAL PRODUCTS.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 2143391 | ARNDT ENDOBRONCHIAL BLOCKER SET | CBI TUBE, TRACHEAL/BRONCHIAL | CBI | COOK INC | N/A | NS14685880 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Unknown |