VSI TURNPIKE SPIRAL 135CM
Report
- Report Number
- 2134812-2024-00045
- Event Type
- Injury
- Date Received
- September 11, 2024
- Date of Event
- June 20, 2024
- Report Date
- August 14, 2024
- Manufacturer
- VASCULAR SOLUTIONS LLC
- Product Code
- DQY
- PMA / PMN Number
- K151981
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CA
- Reporter Occupation
- OTHER
- Health Professional
- N
Narratives
(B)(4).
QN#(B)(4). ADDITIONAL INFORMATION: CASE DETAILS WERE REVIEWED AS REPORTED FROM THE HOSPITAL. IT IS UNKNOWN WHAT DAMAGES WERE PRESENT ON THE SHAFT. THE ADDITIONAL INFORMATION RECEIVED INDICATES THAT THE LESION WAS HEAVILY CALCIFIED. A MINUTE SECTION OF THE TIP BROKE OFF WHICH WAS NOT BIGGER THAN 1 MM. THE TIP DID GET STUCK CROSSING THE LESION. TURNPIKE WAS NOT TORQUED EXCESSIVELY. TIP MIGRATED TO A SMALLER VESSEL. NO PICTURES OF THE TURNPIKE OR FLUOROSCOPIC IMAGES WERE PROVIDED. WITHOUT A PRODUCT RETURN, THE EXTENT OF USE AND HANDLING OF THE DEVICE IS UNKNOWN. A DHR REVIEW WAS COMPLETED LOT 73L2200492 AND NO ISSUES OR NONCONFORMITIES WERE NOTED. NO RETURN PRODUCT EVALUATION COULD BE COMPLETED AS THE DEVICE WAS NOT RETURNED FOR INVESTIGATION. THE IFU STATES THE FOLLOWING WARNING AND PRECAUTION: NEVER ADVANCE, WITHDRAW, OR ROTATE AN INTRAVASCULAR DEVICE AGAINST RESISTANCE UNTIL THE CAUSE OF THE RESISTANCE IS DETERMINED BY F LUOROSCOPY. MOVEMENT OF THE CATHETER OR GUIDEWIRE AGAINST RESISTANCE MAY RESULT IN SEPARATION OF THE CATHETER OR GUIDEWIRE TIP, OTHER DEVICE DAMAGE, OR VESSEL INJURY DO NOT ROTATE THE CATHETER MORE THAN TWO (2) CONSECUTIVE 360 ROTATIONS IN EITHER DIRECTION IF THE DISTAL TIP IS NOT ALSO ROTATING AND ADVANCING, AS IT MAY RESULT IN SEPARATION OF THE CATHETER, DAMAGE TO THE CATHETER, OR VESSEL INJURY. EXERCISE CARE IN HANDLING THE CATHETER DURING A PROCEDURE TO REDUCE THE POSSIBILITY OF ACCIDENTAL BREAKAGE, BENDING, OR KINKING. BASED ON THE INFORMATION, THE MOST LIKELY ROOT CAUSE OF THE ISSUE IS UNDETERMINABLE.
IT WAS REPORTED BY CLINICAL STAFF AT THE HOSPITAL: "WHILE CROSSING A LEFT ANTERIOR DESCENDING LESION, THE TURNPIKE SPIRAL BROKE OFF AND TRAVELLED DOWNSTREAM." ADDITIONAL INFORMATION FROM THE OPERATOR AND STAFF AT THE PROCEDURE: "THE TURNPIKE TIP BECAME DAMAGED ON A HEAVILY CALCIFIED LESION. IT WAS A MINUTE SECTION, NO BIGGER THAN 1MM. THE TIP GOT STUCK WHILE TRYING TO PASS THE LESION. THE PATIENT DIED DURING THE PROCEDURE BECAUSE OF ANATOMY AND CONDITION, AFTER PROLONGED RESUSCITATION. HE HAD SIGNIFICANT CORONARY DISEASE AND WAS TURNED DOWN FOR SURGERY. HE ARRESTED DUE TO LACK OF FLOW, IN A VESSEL NOT RELATED TO THE BROKEN PIECE. THE TIP WENT DOWN INTO A SMALLER VESSEL. IT WAS THE LARGER VESSEL THAT HAD LIMITED FLOW. THE HOSPITAL'S INVESTIGATION DETERMINED THE DEATH OF THE PATIENT WAS NOT RELATED TO THE INCIDENT AND WAS RELATED TO UNDERLYING CONDITIONS."
IT WAS REPORTED BY CLINICAL STAFF AT THE HOSPITAL: "WHILE CROSSING A LEFT ANTERIOR DESCENDING LESION, THE TURNPIKE SPIRAL BROKE OFF AND TRAVELLED DOWNSTREAM." ADDITIONAL INFORMATION FROM THE OPERATOR AND STAFF AT THE PROCEDURE: "THE TURNPIKE TIP BECAME DAMAGED ON A HEAVILY CALCIFIED LESION. IT WAS A MINUTE SECTION, NO BIGGER THAN 1MM. THE TIP GOT STUCK WHILE TRYING TO PASS THE LESION. THE PATIENT DIED DURING THE PROCEDURE BECAUSE OF ANATOMY AND CONDITION, AFTER PROLONGED RESUSCITATION. HE HAD SIGNIFICANT CORONARY DISEASE AND WAS TURNED DOWN FOR SURGERY. HE ARRESTED DUE TO LACK OF FLOW, IN A VESSEL NOT RELATED TO THE BROKEN PIECE. THE TIP WENT DOWN INTO A SMALLER VESSEL. IT WAS THE LARGER VESSEL THAT HAD LIMITED FLOW. THE HOSPITAL'S INVESTIGATION DETERMINED THE DEATH OF THE PATIENT WAS NOT RELATED TO THE INCIDENT AND WAS RELATED TO UNDERLYING CONDITIONS."
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 563081 | VSI TURNPIKE SPIRAL 135CM | CATHETER, PERCUTANEOUS | DQY | VASCULAR SOLUTIONS LLC | 73L2200492 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 74 YR | Male | NOT REPORTED |