ARROW REDIGUARD IAB: 8FR 50CC
Report
- Report Number
- 3010532612-2023-00628
- Event Type
- Injury
- Date Received
- November 2, 2023
- Date of Event
- October 18, 2023
- Report Date
- October 19, 2023
- Manufacturer
- ARROW INTERNATIONAL LLC
- Product Code
- DSP
- PMA / PMN Number
- K010330
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- AL, US
- Reporter Occupation
- OTHER
- Health Professional
- N
Narratives
(B)(4). THE REPORTED COMPLAINT FOR "BALLOON WOULD NOT UNWRAP" WAS NOT ABLE TO BE CONFIRMED AS THE PRODUCT WAS NOT RETURNED FOR INVESTIGATION. A DEVICE HISTORY RECORD (DHR) REVIEW WAS UNABLE TO BE COMPLETED AS NO SERIAL/LOT NUMBER WAS REPORTED. THE ROOT CAUSE OF THE COMPLAINT WAS UNDETERMINED. NO FURTHER ACTION REQUIRED AT THIS TIME. TELEFLEX WILL CONTINUE TO MONITOR AND TREND ON REPORTS OF THIS NATURE.
(B)(4). OTHER REMARKS: N/A CORRECTED DATA: N/A.
(B)(4). IN SECTION D ADDED THE INFORMATION AVAILABLE FOR THE UDI #, THERE WAS NO LOT NUMBER REPORTED. THEREFORE, THE FULL UDI # IS UNABLE TO BE PROVIDED. **UDI RELATED DATA QUALITY UPDATES ONLY** OTHER REMARKS: N/A. CORRECTED DATA: N/A.
IT WAS REPORTED THAT "IAB PLACEMENT ATTEMPTED ON LF, NO ISSUES OR DIFFICULTY NOTED WITH INSERTION, CONSTANT HIGH PRESSURE ALARMS ON PUMP, PUMP EXCHANGED, HIGH PRESSURE ALARMS CONTINUED. VOLUME DECREASED TO 40CC. MANUAL INFLATION NOT ATTEMPTED DUE TO LACK OF VISUAL PLACEMENT (IN OR) CXR CONFIRMED PROPER PLACEMENT. 2ND IAB INSERTED ON RF WITH SAME RESULT. 2ND IAB WAS KEPT FOR RETURN PHOTOS SHOW IAB STILL TIGHTLY WRAPPED. [THE PERFUSIONIST] STATED HE ALSO ATTEMPTED TO INFLATE IAB WITH THE PUMP IN INTERNAL TRIGGER AFTER THE IAB WAS REMOVED. HIGH PRESSURE ALARMS STILL NOTED AND IAB DID NOT UNWRAP. PATIENT WAS MEDICALLY STABILIZED AND TRANSFERRED TO THE ICU WHERE HE REMAINED STABLE WITHOUT IAB PLACEMENT". SEE ASSOCIATED MDR #3010532612-2023-00629.
IT WAS REPORTED THAT "IAB PLACEMENT ATTEMPTED ON LF, NO ISSUES OR DIFFICULTY NOTED WITH INSERTION, CONSTANT HIGH PRESSURE ALARMS ON PUMP, PUMP EXCHANGED, HIGH PRESSURE ALARMS CONTINUED. VOLUME DECREASED TO 40CC. MANUAL INFLATION NOT ATTEMPTED DUE TO LACK OF VISUAL PLACEMENT (IN OR) CXR CONFIRMED PROPER PLACEMENT. 2ND IAB INSERTED ON RF WITH SAME RESULT. 2ND IAB WAS KEPT FOR RETURN PHOTOS SHOW IAB STILL TIGHTLY WRAPPED. (THE PERFUSIONIST) STATED HE ALSO ATTEMPTED TO INFLATE IAB WITH THE PUMP IN INTERNAL TRIGGER AFTER THE IAB WAS REMOVED. HIGH PRESSURE ALARMS STILL NOTED AND IAB DID NOT UNWRAP. PATIENT WAS MEDICALLY STABILIZED AND TRANSFERRED TO THE ICU WHERE HE REMAINED STABLE WITHOUT IAB PLACEMENT". SEE ASSOCIATED MDR #3010532612-2023-00629.
IT WAS REPORTED THAT "IAB PLACEMENT ATTEMPTED ON LF, NO ISSUES OR DIFFICULTY NOTED WITH INSERTION, CONSTANT HIGH PRESSURE ALARMS ON PUMP, PUMP EXCHANGED, HIGH PRESSURE ALARMS CONTINUED. VOLUME DECREASED TO 40CC. MANUAL INFLATION NOT ATTEMPTED DUE TO LACK OF VISUAL PLACEMENT (IN OR) CXR CONFIRMED PROPER PLACEMENT. 2ND IAB INSERTED ON RF WITH SAME RESULT. 2ND IAB WAS KEPT FOR RETURN PHOTOS SHOW IAB STILL TIGHTLY WRAPPED. [THE PERFUSIONIST] STATED HE ALSO ATTEMPTED TO INFLATE IAB WITH THE PUMP IN INTERNAL TRIGGER AFTER THE IAB WAS REMOVED. HIGH PRESSURE ALARMS STILL NOTED AND IAB DID NOT UNWRAP. PATIENT WAS MEDICALLY STABILIZED AND TRANSFERRED TO THE ICU WHERE HE REMAINED STABLE WITHOUT IAB PLACEMENT". SEE ASSOCIATED MDR #3010532612-2023-00629.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 131592 | ARROW REDIGUARD IAB: 8FR 50CC | SYSTEM, BALLOON, INTRA-AORTIC | DSP | ARROW INTERNATIONAL LLC | UNKNOWN |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 80 YR | Male |