RADIFOCUS INTRODUCER
Report
- Report Number
- 9681834-2021-00220
- Event Type
- Malfunction
- Date Received
- December 2, 2021
- Date of Event
- November 5, 2021
- Report Date
- December 2, 2021
- Manufacturer
- TERUMO CORPORATION, ASHITAKA
- Product Code
- DYB
- PMA / PMN Number
- K033681
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- JA
- Reporter Occupation
- PHYSICIAN
- Health Professional
- Yes
Narratives
EXPIRATION DATE - UNKNOWN DUE TO UNKNOWN LOT NUMBER. UDI - NOT REQUIRED FOR THIS PRODUCT CODE. IMPLANTED DATE: DEVICE WAS NOT IMPLANTED. EXPLANTED DATE: DEVICE WAS NOT EXPLANTED. PMA/510(K)- K062858, K082644. DEVICE MANUFACTURER DATE - UNKNOWN DUE TO UNKNOWN LOT NUMBER. THE ACTUAL SAMPLE WAS RECEIVED FOR EVALUATION. VISUAL INSPECTION REVEALED THAT THE SHEATH TUBE HAD BEEN FRACTURED NEAR THE SUPPORTER. MAGNIFYING INSPECTION OF THE ACTUAL SAMPLE REVEALED: THE FRACTURED SECTION HAD AN UNEVEN SHAPE ON BOTH THE DISTAL SIDE AND THE SUPPORTER SIDE. BOTH THE DISTAL SIDE AND THE SUPPORTER SIDE HAD BEEN ELONGATED ON THE FRACTURED SECTION. BOTH THE DISTAL SIDE AND THE SUPPORTER SIDE HAD BEEN FLATTENED ON THE FRACTURED SECTION. SCRATCHES WERE FOUND ON MULTIPLE SECTIONS OF THE SUPPORTER. ELECTRON MICROSCOPIC INSPECTION OF THE ACTUAL SAMPLE REVEALED: A PARTIALLY SMOOTH FRACTURE SURFACE WAS FOUND ON BOTH THE DISTAL SIDE AND THE SUPPORTER SIDE. A PARTIALLY SMOOTH FRACTURE SURFACE WAS FOUND ON BOTH THE DISTAL SIDE AND THE SUPPORTER SIDE. A SCRATCH CONNECTED TO THE FRACTURE SURFACE WAS FOUND IN THE VICINITY OF FRACTURED SECTION ON BOTH THE DISTAL SIDE AND THE SUPPORTER SIDE. A SCRATCH WAS FOUND NEAR THE FRACTURED SECTION ON THE SUPPORTER SIDE. BOTH THE SCRATCH ON THE SUPPORTER HAD A SMOOTH FRACTURE SURFACE. FROM THESE FEATURES, IT WAS INFERRED THAT SOME SHARP OBJECT CAME INTO CONTACT WITH THE SHEATH TUBE AND THEN PULLING FORCE WAS APPLIED. THE PRODUCTION LOT NUMBER WAS NOT PROVIDED BY THE USER FACILITY, WHICH PREVENTED A MEANINGFUL REVIEW OF THE DEVICE HISTORY RECORD. FROM THE STATE OF ACTUAL SAMPLE, IT WAS INFERRED THAT PULLING FORCE WAS APPLIED WHILE THE SHEATH TUBE WAS DAMAGED BY THE BLADE. AS A RESULT OF PERFORMING A SIMULATION TEST, THE FOLLOWING FEATURES WERE FOUND: THE FRACTURED SECTION HAD AN UNEVEN SHAPE. THE FRACTURED SECTION HAD ELONGATED PARTS AND WAS SHAPED LIKE IT WAS TORN. A PARTIALLY SMOOTH FRACTURE SURFACE WAS FOUND. THESE FEATURES WERE LIKELY TO BE SIMILAR TO THE ACTUAL SAMPLE. IFU STATES: DO NOT SCRATCH THE SHEATH WITH NEEDLE POINT, CUTTING TOOL, OR OTHER EDGED TOOLS. BASED ON THE PROVIDED INFORMATION AND INVESTIGATION RESULTS, THERE IS NO DEFINITIVE EVIDENCE THAT THIS EVENT WAS RELATED TO A DEVICE DEFECT OR MALFUNCTION. IT WAS LIKELY THAT SINCE THE SHEATH TUBE AND SUPPORTER OF THE ACTUAL SAMPLE WERE SCRATCHED, IT CAME INTO CONTACT WITH SOME SHARP OBJECT DURING USE. THEN, STARTING FROM THESE SCRATCHES, THE SHEATH TUBE FRACTURED DUE TO THE FORCE WHEN THE ACTUAL SAMPLE WAS REMOVED. THE EXACT CAUSE OF THE REPORTED EVENT CANNOT BE DEFINITIVELY DETERMINED BASED ON THE AVAILABLE INFORMATION. (B)(4).
THE USER FACILITY REPORTED THAT THE RADIFOCUS INTRODUCER LL H WAS USED DURING THE PROCEDURE. WHEN THE SHEATH WAS PULLED OUT, IT FRACTURED ON THE BODY TUBE SIDE (APPROXIMATELY 1CM FROM THE HUB). IT WAS AN EVENT WHEN HEMOSTASIS WAS DONE AFTER THE TREATMENT, AND HEMOSTASIS WAS PERFORMED IMMEDIATELY AFTER THE FRACTURE, AND RECOVERY WAS POSSIBLE. SINCE THE FRACTURED SECTION WAS OUTSIDE THE PATIENT'S BODY, NO FRACTURED PIECE REMAINED INSIDE THE PATIENT'S BODY. THE PATIENT WAS NOT HARMED. THE PROCEDURE OUTCOME WAS NOT REPORTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1815142 | RADIFOCUS INTRODUCER | INTRODUCER, CATHETER | DYB | TERUMO CORPORATION, ASHITAKA | NA | UNK |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Unknown |