SENSATION PLUS 8FR. 50CC IAB & ACCESSORIES (W/PRESSURE TUBES, NO STYLET)
Report
- Report Number
- 2248146-2025-0000801
- Event Type
- Malfunction
- Date Received
- December 2, 2025
- Date of Event
- November 7, 2025
- Report Date
- March 11, 2026
- Manufacturer
- DATASCOPE CORP.
- Product Code
- DSP
- UDI-DI
- 10607567108605
- PMA / PMN Number
- K133074
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- TC
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
- Health Professional
- Yes
Narratives
UPDATED FIELDS: B4, G3, G6, H2, H11. CORRECTED FIELD: D4 (UDI AND LOT NUMBER).
DUE TO THE CHARACTER LIMIT IN THE E1 SECTION, THE FULL EVENT SITE NAME IS: (B)(6) HOSPITAL. DUE TO THE CHARACTER LIMIT IN THE E1 SECTION, THE FULL EVENT ADDRESS IS: (B)(6). THE DEVICE HAS NOT BEEN RETURNED TO THE MANUFACTURER SO WE ARE UNABLE TO COMPLETE AN EVALUATION. IF PROVIDED WE WILL SEND A SUPPLEMENTAL REPORT WITH OUR ADDITIONAL FINDINGS. COMPLAINT RECORD ID 1409414
UPDATED FIELDS - B4, D9 DATE RETURN TO MANUFACTURE, G3, G6, H2, H6 TYPE OF INVESTIGATION, INVESTIGATION FINDINGS, INVESTIGATION CONCLUSIONS, H11. CORRECTED FIELD D9 DEVICE AVAILABLE FOR EVALUATION, H3, H6 COMPONENT CODE. THE IAB WAS RETURNED WITH THE MEMBRANE COMPLETELY UNFOLDED AND BLOOD ON THE EXTERIOR OF THE CATHETER AND BETWEEN CATHETER AND SHEATH. THE RETURNED SHEATH WAS NOT A MAQUET PRODUCT. THE EXTENDER AND PRESSURE TUBING WERE ALSO RETURNED. A KINK WAS FOUND ON THE CATHETER TUBING APPROXIMATELY 49.5CM FROM IAB TIP. A SECOND KINK WAS FOUND ON THE CATHETER TUBING AND INNER LUMEN NEAR THE Y-FITTING APPROXIMATELY 72.6CM FROM IAB TIP. A SENSOR OUTPUT TEST WAS PERFORMED AND A PRESSURE READING COULD NOT BE OBTAINED. THE TECHNICIAN THEN USED AN OPTICAL LIGHT TO DETECT ANY BREAKS IN THE SENSOR'S OPTICAL FIBER AND A BREAK WAS OBSERVED WITHIN THE Y FITTING. THE OPTICAL FIBER WAS FOUND TO BE BROKEN CONFIRMING THE REPORTED PROBLEM. WE ARE UNABLE TO DETERMINE WHEN THIS MAY HAVE OCCURRED. A LOT HISTORY RECORD REVIEW WAS COMPLETED FOR THE REPORTED PRODUCT. NO NONCONFORMANCES WERE FOUND THAT ARE CONSIDERED TO BE RELATED TO THE EVENT. THE FAILURE MODE IS ADDRESSED IN THE RISK FILE AND IS OPERATING WITHIN ITS RISK PROFILE. THE IFU ADDRESSES THE REPORTED FAILURE. THERE WERE NO NCMRS IDENTIFIED WHICH COULD CAUSE OR CONTRIBUTE TO THE REPORTED FAILURE. THE INVESTIGATION DOES NOT INDICATE THAT THE DEVICE WAS INADVERTENTLY RELEASED AS NON CONFORMING OR AN ADULTERATED PRODUCT OR WAS A COUNTERFEIT. THE COMPLAINT HISTORY REVIEW DID NOT IDENTIFY AN ADVERSE TREND (INCREASE IN NUMBER OF COMPLAINTS OVER PAST THREE MONTHS. BASED ON THE RATIONAL PROVIDED ABOVE, NO ESCALATION TO THE CAPA PROCESS IS REQUIRED.
UPDATED FIELDS - B4, D9, G3, G6, H2, H3, H6 (TYPE OF INVESTIGATION, INVESTIGATION FINDINGS, COMPONENT CODE, INVESTIGATION CONCLUSIONS), H11. CORRECTED FIELD: H6 MEDICAL DEVICE PROBLEM CODE. IT WAS REPORTED THAT WHILE SENSATION PLUS 50CC CATHETER INSERTION INTO THE PATIENT, THE MESSAGE OF "SOURCE: TRANSDUCER-NO CABLE" APPEARED ON THE SCREEN IN ADDITION TO FIBER-OPTIC SENSOR FAILURE MESSAGE APPEARED AS WELL.
N/A
IT WAS REPORTED THAT WHILE SENSATION PLUS 50CC CATHETER INSERTION INTO THE PATIENT, THE MESSAGE OF "SOURCE: TRANSDUCER-NO CABLE" APPEARED ON THE SCREEN IN ADDITION TO FIBER-OPTIC SENSOR FAILURE MESSAGE APPEARED AS WELL. NO HARM OR INJURY TO THE PATIENT WAS REPORTED.
N/A.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 161406 | SENSATION PLUS 8FR. 50CC IAB & ACCESSORIES (W/PRESSURE TUBES, NO STYLET) | SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL | DSP | DATASCOPE CORP. | 0684-00-0576-01 | 3000450011 | 10607567108605 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 62 YR | Male | PUMP. |