STARTER GUIDEWIRE
Report
- Report Number
- 9681477-2026-00024
- Event Type
- Injury
- Date Received
- February 25, 2026
- Date of Event
- February 4, 2026
- Report Date
- March 25, 2026
- Manufacturer
- LAKE REGION MEDICAL LIMITED
- Product Code
- DQX
- UDI-DI
- 08714729326731
- PMA / PMN Number
- K935170
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- JA
- Reporter Occupation
- PHYSICIAN
- Health Professional
- Yes
Narratives
A REVIEW OF THE DEVICE HISTORY RECORDS FOR THE SPECIMEN DEVICE DOES NOT PRESENT ANY INDICATION OF MANUFACTURING DEFECT OR ANOMALY THAT COULD HAVE IMPACTED ON THE EVENT AS REPORTED. THE HISTORY RECORDS INDICATE THIS PRODUCT WAS FINAL INSPECTION TESTED AT LAKE REGION MEDICAL AND WAS DETERMINED TO BE ACCEPTABLE. THE DEVICE WAS RETURNED AND A VISUAL AND MICROSCOPIC EXAMINATION OF THE RETURNED PRODUCT WAS COMPLETED, AND THE FOLLOWING FEATURES WERE OBSERVED: - THE GUIDEWIRE IS A 3-PIECE CONSTRUCTION, WITH A COIL, CORE, AND RIBBON. THE COIL, CORE, AND RIBBON ARE WELDED AT THE PROXIMAL END, THE COIL AND RIBBON ARE WELDED AT THE DISTAL END. - THERE WAS A KINK LOCATED AT 15CM FROM THE DISTAL TIP AND BIOLOGICAL MATERIAL WAS NOTED AT 1CM FROM THE DISTAL TIP. - NO ANOMALIES WERE OBSERVED TO INDICATE A MANUFACTURING ISSUE WITH THE DISTAL OR PROXIMAL WELD. A FINGER PULL TEST WAS CARRIED OUT ON BOTH WELDS AND IT WAS CONFIRMED THE TWO WELDS ARE INTACT. - NO OTHER DAMAGE WAS NOTED ON RETURNED GUIDEWIRE. FROM RISK ASSESSMENT COMPLETED FOR THIS PRODUCTS FAILURE MODE IT CAN BE CONCLUDED THAT THE FAILURE MODE IS DOCUMENTED IN THE APPLICABLE DFMEA, AND THE OCCURRENCE RATE IS BEING INVESTIGATED UNDER CAPA-06103. AT THIS TIME, IT IS NOT POSSIBLE TO ASSIGN A DEFINITIVE ROOT CAUSE FOR THE EVENT AS REPORTED. BASED ON THE INFORMATION PROVIDED BY THE SUPPORTING DOCUMENTATION, "EMERGING USE" APPEARS TO HAVE IMPACTED ON THE EVENT AS REPORTED. THE ROOT CAUSE IS UNDETERMINED: CAUSE NOT ESTABLISHED. THE CLASSIFICATION AS REPORTED WAS "FUNCTIONAL: ADVANCING ISSUE" HOWEVER UPON INSPECTION THE CLASSIFICATION AS ANALYSED WAS DETERMINED TO BE "DAMAGED: KINKED". LAKE REGION MEDICAL IS UNABLE TO DETERMINE THE EXACT CAUSE FOR THIS INCIDENT. LAKE REGION MEDICAL HAS NO OPEN PREVENTATIVE ACTION SPECIFIC TO MANUFACTURING THIS PRODUCT DIFFERENTLY. AS INDICATED IN THE IFU (INSTRUCTIONS FOR USE) PRECAUTIONS SECTION: · EXERCISE CARE IN HANDLING OF GUIDEWIRE DURING A PROCEDURE TO REDUCE THE POSSIBILITY OF ACCIDENTAL BREAKAGE, BENDING, KINKING, OR COIL SEPARATION.
AWAITING THE RETURN OF THE DEVICE. A REVIEW OF THE DEVICE HISTORY RECORDS FOR THE SPECIMEN DEVICE DOES NOT PRESENT ANY INDICATION OF MANUFACTURING DEFECT OR ANOMALY THAT COULD HAVE IMPACTED ON THE EVENT AS REPORTED. THE HISTORY RECORDS INDICATE THIS PRODUCT WAS FINAL INSPECTION TESTED AT LAKE REGION MEDICAL AND WAS DETERMINED TO BE ACCEPTABLE.
RELATED PRODUCT MODEL #: 42415. RELATED PRODUCT SERIAL #: NO VALUE FOUND. RELATED PRODUCT UPN #: M001491561. RELATED PRODUCT BATCH/LOT: 0009671426 . RELATED PRODUCT FAMILY: STARTER. MATERIAL NUMBER: M001491561. STERILE LOT NUMBER: NO VALUE FOUND. SOLD TO ACCOUNT NUMBER: NO VALUE FOUND. RETURNED PRODUCT EXPECTED: YES. BSC PRODUCT RETURN DATE: NO VALUE FOUND. LOCATION DESCRIPTION: NO VALUE FOUND. DEVICE/PROCEDURE OUTCOME: PROCEDURE CANCELLED/RESCHEDULED, UNABLE TO USE DEVICE - ATTEMPTED. PATIENT OUTCOME: F2301: ADDITIONAL DEVICE REQUIRED, 104: CANCELLED/RESCHEDULED - POST SEDATION/SEDATION UNKNOWN. EVENT DESCRIPTION: PER CNF, IT WAS REPORTED THAT: -EVENT; HEALTH INJURY OCCURRENCE. -PLEASE INDICATE THE DETAILS OF THE PATIENT HEALTH INJURY OBSERVED.; CARDIAC TAMPONADE -PLEASE INDICATE THE DETAILS OF THE PROCESS LEADING UP TO THE HEALTH INJURY.; SINCE THE POSITION OF THE BROCKENBROUGH WAS NOT OPTIMAL DURING THE FIRST ATTEMPT, THERE SEEMED TO BE RESISTANCE WHEN INSERTING THE WIRE, SO THE PUNCTURE WAS PERFORMED AGAIN. -PLEASE INDICATE THE MEASURES FOR THE HEALTH INJURY THAT OCCURRED.; PERICARDIAL DRAINAGE WAS PERFORMED. -PLEASE INDICATE THE CONDITION OF THE PATIENT AFTER THE TREATMENT.; THE PATIENT'S CONDITION WAS STABLE. -WHAT WAS THE DOCTOR'S OPINION ON THE CAUSE OF THE HEALTH INJURY? IT IS BELIEVED THAT THE POSITION OF THE BROCKENBROUGH DURING THE FIRST ATTEMPT WAS NOT OPTIMAL. -WAS THERE A PROBLEM WITH THE APPEARANCE OR FUNCTIONALITY OF THE DEVICE? NO -WAS THERE ANOTHER CATHETER IN THE HEART WHEN THE ADVERSE EVENT OCCURRED? YES. BEEAT WAS INSERTED IN CS. -WAS THERE ANY RESISTANCE WHILE OPERATING/REMOVING THE DEVICE? YES, THERE WAS RESISTANCE WHILE OPERATING. -IS THE CASE DATA AVAILABLE?; NO -PLEASE INDICATE THE SIZE AND NAME OF THE CONCOMITANT SHEATH.; AGILIS 13 FR NOTE: FOR ANY PATIENT INFORMATION FIELD(S) LEFT BLANK IN THE CNF - "ASKED BUT NOT AVAILABLE AS PER ACCOUNT" NOTE: FOR ANY PATIENT INFORMATION FIELD(S) LEFT BLANK IN THE CNF - "ASKED BUT NOT AVAILABLE AS PER ACCOUNT" PHYSICIAN'S COMMENT: PATIENT OUTCOME: INFECTED: UNKNOWN INFECTION NAME: GENERATOR USED: YES, YES, FARASTAR ABLATION CATHETER USED: YES. NO, FARAWAVE NAV 2.0 OTHER USED: NONE EVENT DATE: 2026-2-4. AS REPORTED DEVICE CODES: 1274: DIFFICULT TO ADVANCE. AS REPORTED PATIENT CODES: 9042: CARDIAC TAMPONADE.
RELATED PRODUCT MODEL #: 42415. RELATED PRODUCT SERIAL #: NO VALUE FOUND. RELATED PRODUCT UPN #: M001491561. RELATED PRODUCT BATCH/LOT: 0009671426 . RELATED PRODUCT FAMILY: STARTER. MATERIAL NUMBER: M001491561. STERILE LOT NUMBER: NO VALUE FOUND. SOLD TO ACCOUNT NUMBER: NO VALUE FOUND. RETURNED PRODUCT EXPECTED: YES. BSC PRODUCT RETURN DATE: NO VALUE FOUND. LOCATION DESCRIPTION: NO VALUE FOUND. DEVICE/PROCEDURE OUTCOME: PROCEDURE CANCELLED/RESCHEDULED,UNABLE TO USE DEVICE - ATTEMPTED. PATIENT OUTCOME: F2301: ADDITIONAL DEVICE REQUIRED, 104: CANCELLED/RESCHEDULED - POST SEDATION/SEDATION UNKNOWN. EVENT DESCRIPTION: PER CNF, IT WAS REPORTED THAT: -EVENT; HEALTH INJURY OCCURRENCE. -PLEASE INDICATE THE DETAILS OF THE PATIENT HEALTH INJURY OBSERVED.; CARDIAC TAMPONADE -PLEASE INDICATE THE DETAILS OF THE PROCESS LEADING UP TO THE HEALTH INJURY.; SINCE THE POSITION OF THE BROCKENBROUGH WAS NOT OPTIMAL DURING THE FIRST ATTEMPT, THERE SEEMED TO BE RESISTANCE WHEN INSERTING THE WIRE, SO THE PUNCTURE WAS PERFORMED AGAIN. -PLEASE INDICATE THE MEASURES FOR THE HEALTH INJURY THAT OCCURRED.; PERICARDIAL DRAINAGE WAS PERFORMED. -PLEASE INDICATE THE CONDITION OF THE PATIENT AFTER THE TREATMENT.; THE PATIENT'S CONDITION WAS STABLE. -WHAT WAS THE DOCTOR'S OPINION ON THE CAUSE OF THE HEALTH INJURY?; IT IS BELIEVED THAT THE POSITION OF THE BROCKENBROUGH DURING THE FIRST ATTEMPT WAS NOT OPTIMAL. -WAS THERE A PROBLEM WITH THE APPEARANCE OR FUNCTIONALITY OF THE DEVICE?; NO -WAS THERE ANOTHER CATHETER IN THE HEART WHEN THE ADVERSE EVENT OCCURRED?; YES. BEEAT WAS INSERTED IN CS. -WAS THERE ANY RESISTANCE WHILE OPERATING/REMOVING THE DEVICE?; YES,[?]THERE WAS RESISTANCE WHILE OPERATING. -IS THE CASE DATA AVAILABLE?; NO -PLEASE INDICATE THE SIZE AND NAME OF THE CONCOMITANT SHEATH.; AGILIS 13 FR NOTE: FOR ANY PATIENT INFORMATION FIELD(S) LEFT BLANK IN THE CNF - "ASKED BUT NOT AVAILABLE AS PER ACCOUNT" NOTE: FOR ANY PATIENT INFORMATION FIELD(S) LEFT BLANK IN THE CNF - "ASKED BUT NOT AVAILABLE AS PER ACCOUNT" PHYSICIAN'S COMMENT: PATIENT OUTCOME: INFECTED: UNKNOWN INFECTION NAME: GENERATOR USED: YES, YES, FARASTAR ABLATION[?]CATHETER USED: YES. NO, FARAWAVE[?]NAV[?]2.0 OTHER USED: NONE EVENT DATE: (B)(6) 2026. AS REPORTED DEVICE CODES: 1274: DIFFICULT TO ADVANCE. AS REPORTED PATIENT CODES: 9042: CARDIAC TAMPONADE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 303947 | STARTER GUIDEWIRE | STARTER GUIDEWIRE | DQX | LAKE REGION MEDICAL LIMITED | M001491561 | 9671426 | 08714729326731 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Unknown | Other |